Podcasts about DCT

Er gehört ganz sicher zu den erfolgreichen Modellen das Hyundai-Konzerns. Und zu den zuverlässigen. Das erkennt man daran, dass Hyundai sein Garantiepaket für den i30 Kombi deutlich verbessert hat. Bis zu acht Jahren oder bis zu 160.000 Kilometer ist man abgesichert. Das ist ein klarer Vorteil für das Portemonnaie. Darum geht es diesmal!Seine Markteinführung erlebte der Hyundai i30 im Jahr 2007 als fünftürige Schräghecklimousine und als Kombi. Mittlerweile ist er in der dritten Generation auch auf unseren Straßen unterwegs.  Bei seinem jüngsten Facelift bekam der i30 Kombi neue Design-Details. So wurden der Kühlergrill, der Stoßfängereinsatz unterhalb des Kennzeichens und die Einfassungen der Nebelscheinwerfer neugestaltet.Power und Drive!    Wie bei den meisten Autos hat man die Qual der Wahl zwischen verschiedenen Antriebsaggregaten. Im Falle das i30 sind das als Einstiegsaggregat der 1.0 T-GDI mit 3-Zylinder-Ottomotor, Turboaufladung und Benzindirekteinspritzung und einer Leistungsausbeute von 74 kW (100 PS). Alternativ gibt es den 1.5 T-GDI 48-Volt-Hybrid. Hier sprechen wir über einen 4-Zylinder-Ottomotor mit Turboaufladung und Benzindirekteinspritzung, über 103 kW (140 PS) Leistung. Beide Motoren sind alternativ mit einem Sechsgang-Schaltgetriebe und einem Siebengang-Doppelkupplungsgetriebe (7-DCT) zu haben. Unser Testkandidat war der 1.5 T-GDI mit Sechsgang-Schaltgetriebe. Der legt den Spurt von 0-100 km/h in 9,8 Sekunden hin, mit der Automatik dauert es eine Zehntelsekunde länger. In der Spitze sind Schaltgetriebe- und Automatikversion mit 197 km/h gleich schnell. Der Verbrauch pendelt sich kombiniert zwischen 5,9 und 6,7 Litern auf 100 Kilometer ein, die CO2-Emission kombiniert nach WLTP bei 133-152 g/km.  Unser 1.5 T-GDI mit seinem 48-Volt-Hybridsystem wird durch einen Startergenerator bei jedem Beschleunigungsvorgang mit bis zu 12 kW Leistung unterstützt. Die dazu notwendigen Energiereserven liefert eine Lithium-Ionen-Speicherbatterie unter dem Gepäckraumboden. Die Kosten!Sie möchten nun natürlich wissen, was der Spaß Sie kostet. Nun, die Spanne liegt beim i30 Kombi aktuell zwischen 28.590, -- € für den 1.0 T-GDI mit Schaltgetriebe in der Advantage – Ausführung und 34.650,00 €. Für den letztgenannten Preis bekommt man den 1.5 T-GDI 48-Volt-Hybrid als N Line mit 7-Gang-DCT. Unser Testfahrzeug lag als Advantage mit Schaltgetriebe bei 30.990,00 €. Alle Fotos: © MMD Automobile GmbH    Diesen Beitrag können Sie nachhören oder downloaden unter:

2022-03-11 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Stacy Hurt (Parexel) for an insightful discussion around the perspective of a patient on the DCT field.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

過往我們都知道Lotus與Toyota集團過從甚密，而其3.5升V6機械增壓動力亦是出自Toyota之手，不過Emira還另外提供Mercedes-AMG 2.0升Turbo動力+8速DCT動力版本，動力來到365hp/3.8kgm，就跑車的角度來說這樣的動力數字不算大，但由於車重僅1446kg，再加上靈巧車身，在山路開起樂趣十足。Emira怎麼個好玩法？和3.5升機械增壓動力在動力輸出特性上有哪些不同？來聽島叔和麥克怎麼說？ 玩車誌網站：⁠⁠https://carfun.tw/>) -- Hosting provided by SoundOn

A British born American citizen, now based out of southwest France, Jacalyn S. Burke is a multi-genre writer and coach with over 30 years of experience across diverse industries. From working with Manhattan's elite as a nanny to leading a tech startup, her journey has shaped her unique understanding of human behavior and storytelling.   Jacalyn is the creator of the DCT 28-Day Life Program, a transformative mindfulness and performance framework for individuals and organizations navigating the AI era. As a writer, her imaginative fiction and insightful nonfiction draw from rich personal experiences. Her portfolio includes, Angel (Random House, 1999) The Nanny Time Bomb (Bloomsbury, 2015) and a thriller series The Custodians (Armin Lear Press, 2024).   Jacalyn's mission is to help creatives, authors, and leaders share their stories, heal through meditation, and inspire transformation in others. She channels a group of beings known as “the 9.”

2025-01-31 Hosts Jane Myles (DTRA) and Michelle Shogren (Innovate In What You Do!) were joined by Rebecca Kottschade (Mayo Clinic) and Caroline Redeker (Advanced Clinical) to share about the work they led at DTRA around Roles and Responsibilities when using decentralized elements in clinical trials.Sites are overburdened with technology and role ambiguity as the use of DCT methods in clinical trials evolve. It is often unclear to sites whose responsibility it is to do what when using DCT methods. Site considerations for implementation of DCTs include training, ongoing support, cost, risk, responsibility, logistics, integrations, and teaching patients how to use and enable the DCT offerings. This team developed a set of questions to be applied before site selection and at site activation to aid in study planning.The newly released work is now available on the DTRA website at: https://www.dtra.org/roles-and-responsibilities-colabYou can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

¡Arrancamos motores en #PuntaDeGas con una historia de pura adrenalina y superación! En este episodio, nos acompaña #Torni (Daniel Alvarez), un motero de corazón que desafió todos los límites tras un accidente que pudo alejarlo de las dos ruedas para siempre. Pero nada detiene a un verdadero apasionado del asfalto. ️ Desde sus primeras aventuras en moto con una Suzuki GSX 750 F y su legendaria #Hayabusa, pasando por la transición a una #VStrom1000 y su fatídico accidente, hasta su inspirador regreso con una #AfricaTwin 1100 DCT, Torni nos cuenta su increíble viaje de resiliencia y amor por las motos. ✨ No te pierdas sus rutas más épicas: ✔️ Viaje en #Vespa hasta #Sevilla con el #VespaTour ✔️ Cruce de los #Pirineos en una ruta llena de curvas, paisajes espectaculares y compañerismo ✔️ Su experiencia en la mítica concentración de #Faro ✔️ La aventura por #Huelva, #Asturias, #Soria y mucho más ️ Un episodio lleno de emociones, anécdotas y la prueba de que la pasión por las motos puede superar cualquier obstáculo. Dale al play y prepárate para sentir la carretera en cada historia. ¡Gaaas! Whatsapp: http://wa.me/34644020615 Email: Damerueda@gmail.com TIENDA: https://www.latostadora.com/shop/damerueda/?shop_trk Encuéntranos en: Youtube: http://www.youtube.com/@damerueda Instagram Dame Rueda: https://acortar.link/bqWGOu Instagram Bicho Raro: https://www.instagram.com/bichoraro_damerueda/?hl=es Instagram Diez-Once: https://www.instagram.com/diezonce_damerueda/?hl=es Facebook: https://www.facebook.com/damerueda Telegram: https://t.me/dameruedagrupo Blog Dame Rueda: https://damerueda.home.blog/ Email: Damerueda@gmail.com TikTok: https://www.tiktok.com/@damerueda?_t=8jFKY9ClhWC&_r=1 #Motolovers #MotoAdventure #Superación #Motociclismo #HondaAfricaTwin #RidersLife #MotoPodcast #RugiendoMotores #HistoriasQueInspiran #PodcastMotero #AventuraSobreDosRuedas #BikerLife #MoterosDelMundo #MoterosEspaña #RutaEnMoto #Gasss

Are the dense jungles of Windows Server leaving you lost? Are Active Directory tangles, Entra ID integrations, or legacy issues keeping your IT nights sleepless? Well, grab your machete (or PowerShell) and join us on an expedition into the depths of Microsoft ecosystems in this week's episode of Data Center Therapy!In this thrilling adventure, your trusted guides, Matt “Server Sherpa” Yette and Matt “Patch Paladin” Cozzolino, are joined once again by IVOXY's own Microsoft guru, Dade “Forest Ranger” Wilson. Together, they brave the wilds of Windows Server and Active Directory to uncover the secrets, pitfalls, and solutions waiting within.What treasures (and traps) await you in this episode?Windows Server Assessment: Dade spills the beans on what his assessment covers, from identifying lurking performance issues to spotting security vulnerabilities in forgotten corners of your environment.Active Directory & Entra ID: How do these two pillars of Microsoft infrastructure intersect, and why do they often make us break a sweat?Best Practices & Pro Tips: Schema upgrades, time-sync nightmares, and why DNS is always the culprit—Dade and the Matts share their survival tips.Upcoming Workshop Alert: Don't miss out on IVOXY's upcoming Active Directory/Entra ID workshop and hands-on training class, led by Dade, designed to demystify these crucial Microsoft tools and set your team up for success.As always, if you enjoy the show, please be sure to like, share with three colleagues and subscribe wherever you get your quality podcasts.From the DCT crew – Stay cool, stay protected, be informed and see you at the next event and episode, compadres

Episode 7 is with the lovely Emma France. Emma runs the famous DCT group and has been instrumental in helping heaps of swimmers achieve their goals of swimming The English Channel. An Accomplished swimmer herself with three solos and twenty EC relays shew knows her onions... Was a pleasure chatting to someone with such a wealth of experience to share. Season 4 is in collaboration with Ocean Lube, the Ocean friendly anti-chafing skin cream that saves your skin and protects our oceans.

The FDA's 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While many still view DCTs as either fully virtual or fully in-person, the guidance promotes a hybrid approach, blending traditional and decentralized elements. This flexibility may help smaller sites participate alongside large academic medical centers, making trials more accessible to rural and underserved areas.However, challenges remain, including regulatory complexities, patient safety concerns, and infrastructure demands—especially for oncology studies, which are inherently intricate and costly. The FDA's choice to issue nonbinding guidance rather than enforceable regulations reflects a desire for progress without lengthy regulatory delays, even as it leaves questions about enforcement and compliance.The guidance hints at using healthcare providers innovatively, potentially improving recruitment and trial access. Still, the reliance on guidance rather than regulations raises concerns about consistency, as auditors often treat nonbinding recommendations as de facto rules.Ultimately, while the DCT model offers promise, particularly for oncology, its success hinges on balancing flexibility with clear standards, empowering both large and small research sites to deliver innovative treatments effectively.Support the show

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA's Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises critical questions for Institutional Review Boards (IRBs). While DCTs have existed for years, the official guidance now provides a framework for utilizing healthcare providers (HCPs), remote modalities, and flexible patient engagement. IRBs must consider:Approval Implications: How decentralized elements affect risk-based assessments and informed consent.Data Validity: Whether varying patient experiences impact trial control and data integrity.Protocol Design: Increased complexities in evaluating sponsor protocols that integrate hybrid or decentralized approaches.2. Human Research Protection Programs (HRPPs): IRBs are components of broader HRPPs, which also encompass research compliance, conflict of interest management, and quality auditing. Accreditation bodies like AAHRPP (gold standard for HRPPs) demand higher standards, which could necessitate additional adjustments to align with FDA guidance.3. Regulatory Overlap and Harmonization Challenges: IRBs must navigate overlapping jurisdiction from the FDA and other entities like the Office for Human Research Protections (OHRP). The lack of harmonized regulations between these agencies creates confusion for researchers and inefficiencies in clinical trial oversight.4. FDA Audits and Oversight of IRBs: While the FDA does not directly regulate IRBs, it audits them and issues warning letters or Form 483 observations. IRBs must remain vigilant about FDA compliance, especially with decentralized elements becoming more common.5. Decentralization's Efficiency Debate: There is no blanket conclusion about whether decentralized trials increase efficiency or diversity. IRBs must assess the appropriateness of decentralized approaches on a case-by-case basis, particularly for complex studies like oncology trials or early-phase research requiring hospital stays.6. Calls for Streamlining Oversight: There is growing discussion about reducing redundancy across regulatory bodies to enhance efficiency and lower costs for patients. However, skepticism remains about whether eliminating overlap would ensure adequate protection for trial participants.7. Future Considerations:Adaptation: IRBs must adapt to increased DCT submissions while maintaining rigorous risk-based evaluations.Consistency: Balancing flexibility in decentralized models with the need for consistent oversight practices.Policy Evolution: Ongoing dialogue on whether accrediting bodies like AAHRPP or agencies like OHRP should develop complementary guidance to align with FDA standards.In 2024, IRBs face a critical moment to address these challenges while ensuring that decentralized innovations do not compromise participant safety or trial integrity.Support the show

Esto es un extracto de la Tertulia de AutoFM que se emite cada jueves en Onda Cero Todo sobre el nuevo EBRO S800: el regreso de una leyenda española La histórica marca española EBRO vuelve al mercado automovilístico tras tres décadas de ausencia con el lanzamiento del S800, un SUV mediano con siete plazas, diseñado para competir con modelos como el KGM Torres, el SEAT Tarraco, el EVO7 y el DFSK 600. Este modelo refuerza la apuesta de EBRO por los todocaminos en su regreso, coincidiendo con el 70 aniversario de la marca. Características principales del EBRO S800 1. Fabricación y dimensiones: • Se ensambla en la Zona Franca de Barcelona gracias a la alianza estratégica con Chery. • Longitud: 4,7 metros. • Disposición interior: siete plazas en configuración 2+3+2. 2. Niveles de equipamiento: • Premium: Incluye elementos como faros LED, pantalla táctil de 15,6 pulgadas, Android Auto, Apple CarPlay, control de crucero adaptativo, y múltiples asistentes de seguridad (detección de punto muerto, frenada autónoma, entre otros). • Luxury (añade al Premium): techo solar panorámico, asientos delanteros con ventilación, masaje y memoria, volante calefactable y un sistema Head-Up Display. 3. Precios en España: • Versión Premium: 36.990 €. • Versión Luxury: 38.990 €. (Precios base sin descuentos ni promociones). Motorización y rendimiento • Motor: 1.6 litros T-GDi de gasolina con cuatro cilindros. • Potencia: 147 CV y 275 Nm de par máximo. • Transmisión: automática DCT de 7 velocidades con tracción delantera. • Velocidad máxima: 180 km/h. • Consumo medio: 7,8 l/100 km (ciclo WLTP). • Emisiones de CO2: 177 g/km. Futuras versiones híbridas enchufables EBRO planea introducir la versión Q Power PHEV, que combinará una potencia total de 347 CV y permitirá recorrer hasta 90 km en modo eléctrico. Este modelo recibirá la etiqueta 0 Emisiones de la DGT, lo que garantizará beneficios en movilidad urbana. Garantía y disponibilidad El EBRO S800 ofrece una garantía de 7 años o 150.000 km (lo que ocurra primero) y ya está disponible en los concesionarios de las principales ciudades de España como Madrid, Barcelona y Valencia. Con su retorno, EBRO refuerza la presencia de la industria automovilística española y apunta a posicionarse entre los referentes del competitivo segmento SUV. Todos los podcast: https://www.podcastmotor.es Twitter: @AutoFmRadio Instagram: https://www.instagram.com/autofmradio/ YouTube: https://www.youtube.com/@AutoFM Contacto: info@autofm.es

We quickly review the fastest cars you can buy for less than $35,000: the 2024 Ford Mustang EcoBoost High-Performance Pack, 2024 Subaru Impreza WRX tS 6MT, 2025 Mazda3 Turbo AWD, 2024 Volkswagen Golf GTI 380 S manual, 2025 Hyundai Elantra N 6MT, 2025 Mini Cooper S and 2024 Toyota GR86 Trueno 6MT (and Subaru BRZ twin). Plus 3 of the quickest – and most expensive – new GT cars on sale today: the 2025 McLaren GTS, 2024 Mercedes-AMG GT63, and 2025 Bentley Continental GT Speed. === The Carmudgeon Show Sponsor, Vredestein Tires: https://www.vredestein.com/ Click here to join the Hagerty Driver's Club: https://bit.ly/Join-HDC-Cammisa-Rev === On this episode of the Carmudgeon Show, Jason vows to go on an all-expenses-paid trip to Lake Tahoe on Hagerty's dime to properly evaluate the van, Jynah's, grip in the snow (now that it's wearing a set of Vredestein Wintrac Pro tires). Then the boys dive into Gran Turismo – no, not the classic Playstation racing simulators – but rather attaining and maintaining high speeds over extended durations. More specifically, the “Old Man GT” episode of Cammisa's Ultimate Drag Race Replay, which features some of the quickest, most expensive, and impractical 4-wheeled jewelry money can buy: the McLaren GTS, Mercedes-AMG GT63, and Bentley Continental GT Speed.  While discussing the new AMG GT63 (which no longer rides on underpinnings from the Dodge Viper lineage like its predecessors, the gullwing-door SLS AMG and the previous AMG GT, but now shares its platform and drivetrain with the SL line), Derek shares a nugget from his vintage Mercedes literature which shows SL buyers in the 1990s had significantly more money to spend than S-Class-buying plebes. And Jason theorizes that SEC owners likely had even more still.  Speaking of the Mercedes, Jason laments that the new SL63's posterior profile looks suspiciously Porsche 911-y, but the duplicative flattery appears to date all the way back to the Porsche 356 and the contemporary Mercedes-Benz W198 300 SL Gullwing.   In other news, Motor Trend Video is dead, and Jason is deeply empathetic.  After the mourning, we delve into the next drag race episode: cars under $35,000! This episode pits the latest crop of cheap speed against one another in bracketed races with nearly every drivetrain orientation: naturally aspirated, turbocharged, front-wheel drive, rear-wheel drive, all-wheel drive, manual, automatic, DCT, and so on. Unabashed boosted 4-cylinder noises assault the senses and appease the Abarth gods. Our first race pits the front-wheel drive cars against one another: the Hyundai Elantra N races the Mk8 Volkswagen GTI and the new F66 Mini Cooper S – which is completely overlooked by enthusiasts in 2024 (and is too cutesy for its own good), yet somehow manages to be effortlessly quick and best the OG hot hatch GTI.  Then, the second race includes the rear- and all-wheel drive cars: the rwd Ford Mustang EcoBoost races the rwd Toyota GR86, the awd Subaru WRX and the surprisingly quick Mazda 3 Turbo AWD.  And all Jason wants for Christmas is a GR86/FR-S/BRZ hatchback with a K24.  Learn more about your ad choices. Visit megaphone.fm/adchoices

Shaun Day joins us to share stories of his unlikely career at Ford, some insight into OEM design, winning the King Of Hammers off road race, why the GT500 has a DCT, and much more.

For American writers, there is something of a quest in American literature to write the great American novel. Such a work would typify the American experience in the same way Homer's epics or Virgil's "Aeneid" did for ancient Greece and Rome, respectively. And while there are many great American novels, there is not one unquestioned work that earns this distinguished honor. Mark Twain, John Steinbeck, Ernest Hemingway, F. Scott Fitzgerald and more have written works commonly lauded as the "great American novel," but have they gotten there? Is the issue settled? What is the great American novel? For English teachers, we have the same quest to, at least, identify such a work. In this episode of DCT, Winston Brady speaks with literature teachers Ali Graziosi, Christina Salinas, and Chelsea Wagenaar, and head of classical education Matt Ogle. Each participant makes a pitch for the book they think is the "Great American novel" and why, along with the criteria as to why they picked that work and not others. What do you think of our criteria? Or of our picks? Did we leave any works out? Be sure to let us in the comments section on your favorite podcasting platform. 

2024-10-10 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Matt Veatch and Aaron Kamauu, hosts of the Real World Wednesday's Club on Clubhouse. We joined forces for a TGIF-DTRA + RWW Crossover Episode! With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT and RWE community for a conversation around this guidance. We discussed why this guidance was aligned to RWE, the distinctions between decentralized, pragmatic, point-of-care trials, and real-world evidence, and how RCTs and DCTs can drive access for all patients.Read the guidance here --> https://www.fda.gov/media/181871/downloadYou can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Join me, Kelly Brothers, for an insightful episode featuring Jeff Phelan, a seasoned real estate developer from Sacramento, as he shares his incredible journey from humble beginnings to building a near-national development company. Listen in as Jeff recounts his early interest in construction, sparked by hands-on summer jobs in Redding, California, and the pivotal role a neighbor, Jim Lenane, played in his career by connecting him with initial opportunities. This episode is a testament to the power of hard work and mentorship, highlighting the importance of instilling a strong work ethic in the younger generation. Jeff Phelan also opens up about the complexities of working for a publicly traded company, his departure from DCT, and the challenges of balancing extensive travel with family life. Discover how Jeff's return to his entrepreneurial roots led to the strategic expansion of Phelan Development across the U.S., with a keen eye on emerging markets like Portland, Oregon. Gain valuable insights into the differences between publicly traded and private companies, and why Jeff prefers the latter. Finally, we explore various real estate trends and the intersection of real estate development with family values and parenting. Jeff discusses the benefits and challenges of different real estate classes, such as office buildings, warehousing, and retail spaces, and shares lessons learned from the Great Recession. We also look into the importance of hands-on experiences for personal growth, the balance of affluence with life's challenges, and succession planning in real estate, including Jeff's perspective on nepotism and preparing the next generation for leadership. This episode is a rich blend of professional insights and personal reflections that really emphasize the true nature and character of who Jeff really is. For more information on what we provide at CAPTRUST visit www.captrust.com. You can contact me, Kelly Brothers, through the show at: bisifipodcast@gmail.com Episode Highlights(02:46 - 04:37) Career Path Influenced by Generous Mentor (11:12 - 12:12) Challenges of Entrepreneurship During Economic Downturn (17:32 - 19:08) Evaluating Potential Real Estate Markets (24:25 - 26:13) Real Estate Challenges and Opportunities (31:11 - 32:39) Strength and Confidence in Logistics Industry (32:40 - 34:27) Challenges of California Real Estate Episode Chapters(00:00) Building a Real Estate Development Company Jeff Phelan's journey from humble beginnings to real estate success, influenced by mentorship and the evolving landscape of the trades. (12:48) Expanding Real Estate Development Company Jeff Phelan's journey from a publicly traded company to restarting his own company, and the strategic expansion of Phelan Development across the U.S. with a focus on emerging markets. (25:02) Analyzing Commercial Real Estate Trends Office buildings have high expenses and tenant turnover, retail is competitive, and warehousing is stable and essential. (36:02) Parenting and Success in Real Estate Real estate development, family values, and parenting intersect with hard work, resilience, and fostering communication and connection within families. (42:39) Succession Planning in Real Estate Nepotism can negatively impact business success, but family involvement can be positive if they have the skills and experience.

It's your first night on-call and you are bleeped at 3am - there's a nasty facial laceration waiting for your urgent attention. You have never sutured the face before…”who you gonna call?” - well sometimes even the Ghostbusters will be more helpful than the on-call trainee! https://youtu.be/3RKZG3yy2sU Watch PDP194 on Youtube Our good friend Dr Ameer Allybocus joins us again for another episode where he gives us a lowdown of his experience when he was a DCT trainee many years ago. There is a lot to learn in this podcast from Ameer as he dives into the Trials and Tribulations of being an Oral and MaxilloFacial Surgery DCT during the early years of his career.  There are laughs and tears in this one, so hold on to your seats for an emotional podcast that will leave you wanting more. Highlights of this Episode:  00:00 Introduction01:37 Protrusive Dental Pearl03:26 Introduction to Dr Ameer Allybocus19:40 The MaxFax Beginnings24:00 MaxFax at UCL29:37 MaxFax isn't all bad36:05 DCT Oral Surgery 42:16 On Call 48:26 Book Recommendations49:15 Working at the Queen Elizabeth Hospital54:13 A Life Changing Experience59:57 MaxFax: Benefits, Tips & Tricks65:26 Tips from Ameer66:25 Trauma and Accidents70:56 MaxFax Puts Dentistry Into Perspective74:33 Closing Words For the full educational experience, our Ultimate Education Plan gives you access to all our courses, webinars, and exclusive monthly content. If you liked this episode, you will also like: Getting Ahead after Dental School 2023 – IC042 – Protrusive Dental Podcast

Hot enough for you, Data Center Therapy listeners?Go ahead, grab a plate of ribs, corn, and green beans, and belly up to the listening picnic table, as your ears get to feast on the freshness that is Episode 94.  In this one, our sun-drenched hosts, Mr. Matt “8 Panel Chamois” Yette and Mr. Matt “Deep Cycle Marine” Cozzolino share their summer exploits along with a healthy heaping of topical news items from the world of I.T.In this episode, you, our loyal DCT fans, will get to hear about:The durability issues plaguing Intel's 13th and 14th generation CPUs, along with their announced layoffsSoftware testing, and some relevant details surrounding the CrowdStrike incident that affected millions of Windows systems worldwideThe complications that affect storage management and backups surrounding Docker containersWhile the boys also muse about the vagaries of automated testing suites and forced updates of software (both on desktop and mobile platforms) the Matts also discuss their latest home lab upgrades, StarLink on boats, and much more.  Give it a listen and get your healthy dose of I.T. empathy from DCT.Reminders: The Aria Operations Workshop is August 8th; register for it here.The Aria Operations Class is September 24th; register for it here.The in-person IVOXY VMware Explore Redux Event in Portland, Olympia and Seattle are September 10th, 11th, and 12th, register for those events here:9/10/24 - Portland, OR9/11/24 - Olympia, WA9/12/24 - Seattle, WAAs always, if you enjoy the show, please be sure to like, share with three colleagues and subscribe wherever you get your quality podcasts.  From the DCT crew - Stay cool, stay protected, be informed and see you at the next event and episode, compadres! 

In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates for patient-centric practices, and underscores the roles of telehealth and AI in research, promoting transparency and ethical standards in clinical research operations. 1. What are the key challenges faced by clinical trial sites?2. How can we ensure that sites have a platform to voice their concerns?3. What is Save our sites?4. Why SCOPE and ACRP may not be suitable platforms for sites?5. How can we address the economics of running a conference when we do need people to buy those slots?6. What is the incentive for individual sites to speak up?7. The Decentralized Clinical Trials Controversy and Citizen Petitions8. The role of Telehealth in Clinical Research9. Does a DCT eliminate the need for localized PIs?10. The Future of AI in Clinical ResearchCheck out Daniel Fox's websites:CRPN- crpn.crpaynet.comSave Our Sites- www.saveoursites.comWhite paper- https://lnkd.in/ek9_NNT7YouTube: @CRPNCentral Support the Show.

What things Microsoft lurk in the shadows, basements, and dark closets of your I.T. organization?  Which parts of Active Directory, Exchange, or M365 keep you up at night, racked with anxiety and fear?  Is there no relief from scary upgrades and failures to be had? Fear not, loyal compatriots! Bust out your flashlights, proton packs, and ectoplasm-resistant onesies because this week on Data Center Therapy, your hosts, Matt ‘Venkman' Yette and Matt ‘Ray' Cozzolino welcome IVOXY's newest Consultant and Microsoft Specialist, Mr. Dade ‘Egon' Wilson to the virtual studios to explore all things ‘365.'   In this episode you, our captivated listeners, will:Hear about Dade's background, his hobbies, love of Seattle, and what he does in his spare time.Find out if schema upgrades should be feared, whether Microsoft had constraints of what the backing storage of Exchange had to be, and why functional version upgrades are often neglected.Learn of the new integrations like Intune and Entra ID which necessitate newer software infrastructure parts and pieces.and be amazed by the myriad of ways in which Microsoft systems can break, whether it's DNS, Kerberos, Certificates, or the time (but we all know, it's DNS!).Come listen to this episode to meet the newest member of the IVOXY team and jump into the deep end of the Active Directory pool with us; it'll be intimidating, but also a bit of a fun.  Register for Matt Cozzolino's upcoming June 20th “Ask me Anything” for his Networking for Server Administrators class (coming July 30th) at https://ivoxy.com/n4sa.  Register for the Aria Operations workshop, coming up August 8th, at https://ivoxy.com/ariaworkshop.  As always, if you enjoyed this episode, please be sure to like, share, and subscribe and tell three friends about how you get a hearty dose of I.T. empathy and free counseling just by listening to the show.  :)  Thanks for listening and we'll see you on the next spooky episode, DCT faithful! 

2024-06-07 Host Craig Lipset was joined by a special guest host, Jean Sposaro (BMS) for our session around Sponsor Experience Implementing DCTs. TransCelerate Bio Pharma conducted a survey in 2023 to better understand the collective experience of TransCelerate members deploying decentralized clinical trial (DCT) elements beyond the COVID-19 pandemic. Ashley Butler (TransCelerate) and Joachim Lovin (Novo Nordisk) joined us for the discussion. TransCelerate's recently released whitepaper can be found here --> https://www.transceleratebiopharmainc.com/wp-content/uploads/2024/04/Sponsor-Experience-Implementing-Decentralized-Clinical-Trial-DCT-Elements-DCT-Implementation-Survey-Results_vFINAL-1.pdfYou can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Welcome back for another new episode, Data Center Therapy aficionados!  This week, our adventurous and hard-working hosts, Matt “Master Link” Yette and Matt “Chromed Crankset” Cozzolino open up the virtual studios to IVOXY's own Ryan “Security Gusset” Grelck, who joins the fellas to talk all things endpoint-related for the first part of the podcast.In addition to discussions of all things client-related, the crew also discuss:The differences between endpoint protection (EPP) and endpoint detection and response (EDR).SentinelOne's purple.ai feature and automated root cause analysis (RCA).Microsoft's Recall feature for Copilot+ PCs, and its security implications.The browser wars, Firefox, and how Chromium code maintenance impacts modern browser platforms.With all those topics and more, including the upcoming Q3 and Q4 classes from IVOXY, the Matts and Ryan also briefly cover the newer software suites now included in VMware vSphere Foundation and VMware Cloud Foundation.  We hope you have as much fun listening to the show as much as we had making it, and if you do, be sure to tell three friends, like and subscribe wherever you find your quality podcasts.  Thanks for joining us once again and we'll see you in an IVOXY class, on a free webinar or on the next episode of DCT.  Ciao for now! 

2024-05-31 Hosts Amir Kalali and Jane Myles joined allowed guests to join as ask their burning questions about all things DCT. A discussion about the EX-US Market in Japan, adoption of DCT methods, and more were addressed during the live session.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Welcome back, long-awaiting listeners, as your favorite IT podcast with a healthy dose of empathy, Data Center Therapy, returns after a seven-month hiatus.  It's been too long, we know, but we're back and we're recharged so we can bring you the first of many new episodes with exciting, topical and relevant content.  Thanks for joining us!On this episode, your intrepid hosts, Mr. Matt “been through the desert on a horse with no name” Cozzolino and Mr. Matt “Call me Heisenberg” Yette share Cozzo's adventures hiking from Supai to Havasupai Falls in the great state of Arizona, and talk all things Broadcom, given the big news of the acquisition of VMware completed since the last episode aired.While sharing their thoughts on the whole VMware ecosystem and the changes, the DCT crew muse about:The new tiers of subscription licensing that replace many of the old VMware SKUs,The changes in licensing from sockets to cores,The aborted licensing change back in the VMware days regarding vRAM,The “second day” about face on ROBO licensingViable alternatives to vSphereThe spinning off of the Horizon technology to the new firm named Omnissa,and much, much more.As a reminder, IVOXY are hosting a vSphere 8 Advanced Class in just two weeks, and we're developing classes and workshops for Disaster Recovery and Aria Operations (formerly VMware vRealize Operations.)  If you're interested in Matt Cozzolino's Networking for Server admins Ask Me Anything on June 20th at 11AM Pacific, register at: https://ivoxy.com/ama-networkingforserveradmins.   If you're looking for the DirtFish 2024 event registration, it may be found at: https://ivoxy.com/dirtfish2024.  As always, if you enjoy Data Center Therapy, please tell three friends and be sure to like, share and subscribe wherever you get your podcasts.  Thanks for your patience, your attention, and we eagerly look forward to sharing more in 2024 with you all on the next episode of Data Center Therapy!

Alice Lin, DCT Solutions Director in the DCT Business Department of Tigermed Consulting, a global CRO, contract research organization, that provides biopharmaceutical and medical device companies with a range of services including digital technology to conduct decentralized clinical trials. Their approach focuses on patient-centricity, efficiency, and adaptability. By utilizing digital tools such as virtual visits, wearable devices, and mobile apps, Tigermed aims to make clinical trials more accessible and convenient for patients, improving recruitment and retention rates. They also emphasize the importance of DCT in including a diverse patient population in trials, particularly for rare diseases. Alice explains, "While our headquarters is in China, we have grown into a global team of over 10,000 employees operating across over 180 locations worldwide. We recently celebrated our 20th anniversary, making two decades of dedicated collaborations with over 2,800 customers on their product journeys. DCT stands for decentralized clinical trials, which involves applying digital technologies to conduct clinical trials. Traditionally, most clinical trial activities are conducted at clinical sites. Still, with DCT, we can conduct some or even all of the trial procedures outside of these sites using digital technology." "Currently, the hybrid DCT model is a common thing in clinical trials. It means some of the trial procedures could be conducted outside of clinical sites, but still keep some clinical trial activities at clinical sites. In our Tigermed DCT department, we are responsible for identifying the appropriate digital technologies for using in clinical trials, whether through self-development or collaboration with the various digital technology companies. We also manage the DCT daily operations in each clinical trial from the study beginning to the study completion." "However, we get that every investigational product and the therapeutic areas bring its own set of challenges and patient needs. So, we make it a priority to figure out what digital tools work best for each study. Our CEO, Dr. Cao, and our head of the DCT business department always say our goal is not just to do decentralized clinical trials for the sake of it. It's about giving patients and caregivers options that fit their needs. This approach means patients and caregivers get solutions that work for them, showing that we are all about being flexible to what they need. Our decentralized clinical trials are all about making things easier for patients, lightening the load for our caregivers, and making the whole trial experience better for all stakeholders involved." #TigermedGRP #CRO #ContractResearchOrganization #DCT #DecentralizedClinicalTrials #MedTech #RemoteMonitoring TigermedGRP.com Download the transcript here

Alice Lin, DCT Solutions Director in the DCT Business Department of Tigermed Consulting, a global CRO, contract research organization, that provides biopharmaceutical and medical device companies with a range of services including digital technology to conduct decentralized clinical trials. Their approach focuses on patient-centricity, efficiency, and adaptability. By utilizing digital tools such as virtual visits, wearable devices, and mobile apps, Tigermed aims to make clinical trials more accessible and convenient for patients, improving recruitment and retention rates. They also emphasize the importance of DCT in including a diverse patient population in trials, particularly for rare diseases. Alice explains, "While our headquarters is in China, we have grown into a global team of over 10,000 employees operating across over 180 locations worldwide. We recently celebrated our 20th anniversary, making two decades of dedicated collaborations with over 2,800 customers on their product journeys. DCT stands for decentralized clinical trials, which involves applying digital technologies to conduct clinical trials. Traditionally, most clinical trial activities are conducted at clinical sites. Still, with DCT, we can conduct some or even all of the trial procedures outside of these sites using digital technology." "Currently, the hybrid DCT model is a common thing in clinical trials. It means some of the trial procedures could be conducted outside of clinical sites, but still keep some clinical trial activities at clinical sites. In our Tigermed DCT department, we are responsible for identifying the appropriate digital technologies for using in clinical trials, whether through self-development or collaboration with the various digital technology companies. We also manage the DCT daily operations in each clinical trial from the study beginning to the study completion." "However, we get that every investigational product and the therapeutic areas bring its own set of challenges and patient needs. So, we make it a priority to figure out what digital tools work best for each study. Our CEO, Dr. Cao, and our head of the DCT business department always say our goal is not just to do decentralized clinical trials for the sake of it. It's about giving patients and caregivers options that fit their needs. This approach means patients and caregivers get solutions that work for them, showing that we are all about being flexible to what they need. Our decentralized clinical trials are all about making things easier for patients, lightening the load for our caregivers, and making the whole trial experience better for all stakeholders involved." #TigermedGRP #CRO #ContractResearchOrganization #DCT #DecentralizedClinicalTrials #MedTech #RemoteMonitoring TigermedGRP.com Listen to the podcast here

How can shifting mindsets fuel the next wave of innovation in the pharmaceutical and life sciences industry? In what ways can we ensure the vast amounts of health data are utilized securely and effectively to foster groundbreaking medical advancements? And how is Oracle's new Health Data Intelligence poised to transform the industry in an unprecedented manner? You'll learn all that and more with our guest Michael Fronstin, Vice President and Chief Commercial Officer at Oracle Life Sciences, who has worked across nearly every area of the industry from positions at Merck to J&J to Kantar Health and now at Oracle.   --------------------------------------------------------   Episode Transcript:   00;00;00;04 - 00;00;26;25 In what ways do the mindsets in the pharma industry need to change? How can we make sure massive amounts of health data is applied to practical effect? And how might Oracle's new Health Data Intelligence platform be an unprecedented game changer? We'll find all that out and more on Research in Action. Hello, welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;26;25 - 00;00;49;15 I'm Mike Stiles. And today we've got a guest who's been a veteran in the life sciences industry and who knows Oracle Life Sciences quite intimately because the guest is Michael Fronstin, vice president and chief commercial officer at Oracle Life Sciences. He's worked across nearly every area of life sciences, from positions at Merck to J&J to Kantar Health and now at Oracle.   00;00;49;15 - 00;01;11;25 So, Michael, thanks for being here. Thanks, Mike. Happy to be here and thank you so much for hosting this session. Really appreciate it. Great. Well, you know, you're the perfect person to talk to about what I want to talk about, which is changing people's minds and changing how we even approach and think about life sciences. So you've got that to look forward to.   00;01;11;25 - 00;01;34;28 But first, let's learn a little bit more about you. How did your interests and opportunities in life take you down the path that led you to where you are now? Yeah, thanks for that question. That's that's a great question to start out with. I'll tell you that as human beings, we all have something going on in terms of health care, whether it's impacting ourselves or friends or family, everyone's going through something.   00;01;34;28 - 00;01;56;25 At some point. You just don't know what the magnitude is or how long lasting, right? So having patience and empathy is so important. And of course myself, I've gone through things and unfortunately starting at a very early age of 12, I lost my best friend to the brain cancer and from the time I was 12 to the time I was 21, unfortunately, I lost a lot of people to different health ailments.   00;01;57;11 - 00;02;17;10 I guess, climaxing with losing my father when I was 21 years old. During that time, I always thought about health care and how it was impacting the people around me and wondering what could I do? And I felt pretty helpless, to be honest with you during those times, because some young boy don't there and there really wasn't anything I can do.   00;02;17;10 - 00;02;35;01 But as I got older and I went into college, I realized I could make a difference in health care. And that was going to be the industry that I was going to focus on. So I went into social sciences, became a sociologist with a business math background, and went to graduate school for an MBA in health care arbitration.   00;02;35;10 - 00;02;56;07 And that's when really things opened up to me where I started saying, okay, what aspect do I like? Where can I make a scalable impact? And I ended up joining Humana A down in Florida for a year or so, realizing that I can make a difference there and get people enrolled, help them get claims processed and paid. And from there my career took off.   00;02;56;07 - 00;03;21;02 I end up going to Merck, carried the bag and really experience the in office experience back in the days of the early nineties in terms of what patients were experiencing, seeing doctors who were really, really good and so much good at diagnosing patients and treating them in a time where most of the chronic conditions didn't have treatments available and new ones were coming out.   00;03;21;16 - 00;03;53;06 And I'll tell you, it was pretty exciting during these times being at Merck and seeing all these innovations. But I'll tell you, during that time I was really able to focus on one therapeutic area and it wasn't very scalable. It wasn't really having the impact it wanted. And it wasn't until I came to the consulting side of the business, you know, working with dozens of customers and maybe hundreds of brands over the past 20 plus years where I really felt like maybe a direct and indirect impact on people's lives around the globe.   00;03;53;28 - 00;04;16;02 So that's that brings me to today. And now I'm with Oracle Life Sciences, where I feel like it's even bigger and broader and better. So I'm excited about the present. I'm excited about the future. Yeah. You mentioned you kept repeating a phrase that kind of struck stuck with me, which is that you wanted to make a difference. Is that hard to do in the health care space?   00;04;16;02 - 00;04;39;12 I mean, have you been gratified by your ability to do that or has it always been a push and pull? Oh, interesting question. Definitely a push. And so, you know, sometimes you can you can make decisions and get them executed very quickly. Other times, it takes a while to do. You know, you have regulatory bodies that you have to deal with different types of payers around the world.   00;04;39;22 - 00;05;04;19 Decisions are always made quickly. And if it's the right decision because of various reasons, whether it's bureaucracy or internal or external, or you need to generate real world evidence modeling or even publications, we have more than 2000, maybe 3000 publications, and you develop the evidence, you submit the publication. It could take, you know, six months, a year, two years to get it published right?   00;05;04;19 - 00;05;24;14 So things just take time, unfortunately. But yeah, you can make a difference. I feel like I've made a difference. I feel pretty gratified about what I've done. And in the areas of the impact that I've made. So and a lot of it is just make an impact within your world and hoping that you can expand it beyond to make a broader impact.   00;05;24;14 - 00;05;59;11 You were at Kantar Health for like 17 years or so. How did what Kantar does align with Oracle Life Sciences and the idea behind just leveraging technology to benefit customers and partners? I'm actually coming on 19 years since we think about it and you mention it. So when I step back and think about my time at Bert or Change in Merck and the broader industry, life science clients need to accomplish three things in order to get their compound, whether new or existing compound, really the new compounds into the hands of the appropriate patients.   00;05;59;11 - 00;06;24;18 They need to get their drugs approved right by some regulatory authority. They need to get them reimbursed and they need to have a strong launch to drive awareness. Otherwise no one's going to prescribe it or patients. People aren't going to request it, right. So those three things need to need to occur. Kanter Health is really focused on the second and third in terms of the research services and expertise.   00;06;25;00 - 00;07;10;02 So the types of people are. Kanter Help are methodologies, social scientists like epidemiologists, psycho nutrition, these these are the folks that know how to design and conduct research, how to consult on the research from a Real-World evidence perspective and driving insights, evidence from a commercial planning perspective, prioritization, things like that. Where is the Oracle Life Sciences group? The other side of the group is really all about technology and applications predominantly focused on driving clinical trials for regulatory approval, of course, and in the area of pharmacovigilance during those trials and tracking them when those products are in the real world.   00;07;10;06 - 00;07;38;08 Right. Post-marketing authorization. So when you bring these two groups together and these types of people together, the technology, the medical intelligence, the scientific, methodological experience of the cancer health folks, have you got the best of all worlds, right? Technology, data experience combined. You take these wraparound services with the technology in and now our clients are able to see a much higher level of value, if you will.   00;07;38;23 - 00;08;02;25 Well, you've actually been anything but shy in the past about saying how the mindsets in the pharma industry really need to change. So what is the current mindset? And in what ways is it limiting? I'll tell you, the health care industry, including life sciences, has always been a little bit of a laggard in terms of of our movement.   00;08;03;11 - 00;08;30;15 Part of that issue is that we we operate in silos, right? And even within our life science clients or customers, the different cross-functional teams don't always come together. They don't know each other. Sometimes they buy the same data, right? So the inefficiencies of spending more budget than they need to, we're not leveraging the same data for different purposes, and we really need to break down the silos.   00;08;30;29 - 00;08;53;15 I think that from a mindset perspective, individuals on every side of the business really need to step back and pick up their heads and look around, see the big picture, understand where are we going? The data is critically important. Big data was becoming the buzzword ten, 15 years ago, but no one really knew what that B meant. Well, now it's here.   00;08;53;22 - 00;09;14;06 We could do something with big data, right? Is sort of on the fringe. Some people are using it, some people aren't, there hasn't. So this is a time where you could either bury your head in the sand because you don't understand it or you're afraid of it, or you can lean in and figure it out. And if you don't lean in, you're going to be left behind.   00;09;14;06 - 00;09;45;01 So I think we need to break down the silos. People need to step back and see the big picture. And I think they need to take risks and and lean in and it Oracle, that's what we're doing. We're committed to helping, you know, through creating open ecosystems, to breaking down barriers across teams, using our teams. And, you know, hopefully everybody will wind up picking your head up and looking at the big picture and caring more about collaboration and how these things can improve so that innovation moves forward faster.   00;09;45;17 - 00;10;06;25 Is that a realistic ask? I mean, I assume researchers are very busy with their heads down working on what they're working on. Can they can they expand and broaden their view? They have that luxury, Absolutely. It's like anything else, you just have to make the time. You got to take the time to make the time, invest the time to figure it out.   00;10;06;25 - 00;10;26;26 It's not easy. And I'm not saying it's easy by any means, but it's worth it to do. And I remember when I was a rep with Merck, you know, moving to Pennsylvania, the Home Office, the analysis, one of my problems that you get there and if you want pieces of advice when you get there, keep your head up.   00;10;27;13 - 00;10;51;11 And I said, I'm always positive. He said, that's not what he said. Look around, understand what's around you, incorporate it, immerse yourself in things you don't understand. You know, be comfortable being uncomfortable and again, new job, new new house placeholders. How do we find the time, how to figure it out? Right. And I see the people around me and our clients.   00;10;51;11 - 00;11;18;18 I see the people around me at Oracle Life Sciences. The ones who are doing that are the ones that are being most successful. Yeah, I love that. Get, get comfortable being uncomfortable. That's not something people dive into, as is uncomfortableness. But, you know, I don't care if it's industry, politics or even favorite flavor of ice cream. Getting anyone these days to change their mind or change their mindset is really hard.   00;11;18;18 - 00;11;49;09 So getting an industry to collectively think differently, that can't be easy. So what do you see as the biggest challenges to that? And is it that there needs to be some driving force for that? And is that the role Oracle's trying to play? Yeah, it's not easy for sure. All right. So some of the biggest challenges are really the cultures that are existing within and across the industry where people are so busy, right?   00;11;49;11 - 00;12;16;11 They're not set up to work. Cross-functionally The siloed nature that's that's occurring across our industry, even in between clinical care and clinical research, there are gaps. So I think all these different places are causing, you know, challenges in terms of making a difference, getting immersed and taking those risks. People aren't always rewarded for taking risks. So let's say it happens.   00;12;16;11 - 00;12;40;29 Let's say there's a shift in mindset and we're thinking more about leading with knowledge and information and looking at that big picture. What opportunities does that present for both the industry and for me when I get sick? Yeah, no, that's a great question as well. So for the industry, I think we'll be able to actually bring compounds to the to the marketplace more quickly.   00;12;41;10 - 00;13;30;00 Right. For you as an individual or us as individuals, all of us will be able to have more options, both clinical research as a care option. Right? Right now, only 3% of eligible patients participate in a clinical trial. Right. If we're able to take information and put it back in the electronic health record or h.r. System so that doctors can look at it at the point of care and make decisions whether it's about what is your care that they want to prescribe or it's about how are these products impacting you as a patient from a pharmacovigilance or really a tolerability or safety perspective, they're able to adjust very quickly right there on the fly, right?   00;13;30;00 - 00;13;51;29 They'll have more data at their fingertips, as we put it in. And that also could be recruiting patients into clinical trials. Right. So they don't know what's the inclusion exclusion criteria. Look it up. So how can you at their fingertips and knowing that this patient can just walk in the door for these patients scheduled to walk in this week, they're eligible.   00;13;52;00 - 00;14;12;02 Let me make sure that I talk to them about that so that they have other options that will help them get well. Yeah, So it's a good payoff. Your answer to this can be Mike, why don't you just mind your own business, but ask Oracle recently combined their Oracle Health and their Oracle Life Sciences divisions. Why did they do that?   00;14;12;11 - 00;14;37;06 Well, I'll tell you, I won't tell you to mind your own business. This is sort of the the biggest payoff I think we're seeing is movement that we've seen in health care. So the acquisition of Cerner by Oracle was just enormous. And it Cerner, these are your cancer health group is part of it really also was a big deal, right?   00;14;37;12 - 00;15;06;10 Because now we can take what's happening in health, in the clinic, in the hospital, in the offices and combine it with life sciences. Everybody has the same goal, which is to save lives or to increase quality of life of patients. But both of these groups, the hospital systems around the world and the life science companies around the world, they're not connected, right?   00;15;06;10 - 00;15;40;22 They want to be connected. They want to intersect, but they're working in silos, trying to influence each other when they both have the same goals, which is to save lives or help people. And now with Oracle Health and Oracle Life Sciences being under not only the same umbrella of Oracle, but under the same leadership in terms of team of firms, we're able to break down the silos so that we're able to share the appropriate data and information in an open equal ecosystem in bi directional way.   00;15;41;11 - 00;16;09;04 And while these two groups are deeply intertwined, yet this distinct, if you will, there are innovations there that we're looking at that will help everybody that some of the migrations celebrate recruitment, sharing of data, point of care decisions, things of that nature. So it's about turning data into information, that information into insights with some kind of open, intelligent, cloud based platform.   00;16;09;27 - 00;16;39;24 There is the problem, though, of drowning in data, but starving for insight that's applicable to so many businesses across so many industries. How would the ecosystem that you just described keep life sciences customers from drowning in data that is never used for practical effect? They're absolutely drowning in data. There are more data sources existing secondary data sources in the industry and across the world today.   00;16;40;05 - 00;17;12;02 The majority of these like probably 98% of them are not unified, they're not connected, and interoperability is lacking. Credit card companies figured it out a long time ago when healthcare has and we're starting to get there. Training unified platform of data Health data intelligence platform is what we call it in Oracle, backed by the Oracle cloud infrastructure. So you have data that's very sensitive sovereignty of nations, you're using it.   00;17;13;04 - 00;17;58;11 And of course OCI, Oracle Cloud Infrastructure affords the opportunity for security and speed and all these other benefits. So the more of tokenization we could do to connect the charged with other h.r. Claims with patient reported outcomes survey. The more we can do that in standardized ways with the right governance will help our clients sort through this sea of information so that we can and will help them, of course, you know, focus on what's important, you know, and use A.I. to define the trends in predictive analysis, what predicts better or worse outcomes.   00;17;59;01 - 00;18;21;22 So it's going to take time. We're getting there. We're already making a lot of progress, but I think that's now how we're going to help our clients get there. Well, I did ask about the obstacles of changing overall mindsets, but what are the remaining obstacles to actually building and implementing this eco system that you're talking about? Are there remaining tech obstacles?   00;18;21;22 - 00;18;50;01 Are there privacy issues? I mean, what's what's there that's making this a tough job? Not only we drowning in data, we're drowning in obstacles like that. So certainly you know, that's an obstacle of legalities around the world. Cultural changes and mindsets. Like we mentioned, there's governance. Who owns the data? We get data right to the data technology. Then we go back to that for a second.   00;18;50;11 - 00;19;13;28 You know, how do we connect from one system to the other? I do believe there's still 300 EHR systems out there. The interoperability, governance image. I mean, we're just not sure about. Also, we got to kick them off one at a time. And you know what we're doing at Oracle and Oracle Life Sciences is we're partnering with a lot of different organizing that's out there.   00;19;14;06 - 00;19;50;17 You might have seen our partnerships with the video code here. Johnson Labs, from algorithms, Perspectives. We're partnering with a lot of other organizations to help chip away at these obstacles and get to this ecosystem that we're talking about, where everybody wants. Yeah, you know, when you when you list those obstacles, one thing that's not there is resistance by patients, because I think most of us, you know, it's kind of a joke amongst everybody how every time you go to the doctor, you fill out the same forms again and again and again and again.   00;19;50;27 - 00;20;14;15 Clearly, there's not any kind of centralized clearinghouse for data on me as a patient. And I think most of the public kind of What's that? What's your view on meeting patient expectations where that's concerned? You know, isn't that the most important thing right of the whole conversation is putting the patient at the center of meeting their expectations. Okay.   00;20;14;15 - 00;20;41;03 There are a couple of countries where this is already occurring with the patients. The is all in one place. The patient just pulls up their app and they go and it doesn't matter which doctor or hospital you're walking into or what country they're visiting when they're traveling, they have their medical records in their pocket. One of the articles of issues is around privacy, and you might have mentioned this.   00;20;41;16 - 00;21;12;16 So in the US we have hip in Europe yard and this is trying to protect the patient for the right reasons. But we have to and we have to work within these systems to make sure we're able to operate together for the patients. There's nothing more annoying walking at your doctor's office and filling out the same or complaint or consent form or insurance form or whatever it is, you know, and it's certainly something that we need to do.   00;21;13;04 - 00;21;46;07 I think from a cohort perspective, the older populations and I'm not sure where that likes it's at 40 or 50 or 60, I think they're a little bit more protective and reticent about their privacy and their information. Whereas I see the younger generations, they're like, it makes sense to share it all the time. I wanted out less concerned about privacy, and maybe it's because of how they've grown up with the apps, social media, you know, everything's out there, you know?   00;21;46;08 - 00;22;09;17 So I think the trend is here and the tide is turning. You know, we have to find ways to continue to meet the patients and people where they are. Well, I'm sticking with that patient theme. There's how patients are involved or not in research. And we are hearing more about patient centered outcomes in research. It's another kind of mind shift that needs to happen.   00;22;09;17 - 00;22;35;04 How are we moving toward that where we're listening to the patient more and involving them more in clinical research than we used to? And that's that's the next great question. You threw that statistic out there that what, there's like 30% participation? I mean, there's clearly an issue. Yeah, Yeah, for sure. So patient reporting outcomes are typically subjective nature, right?   00;22;35;04 - 00;23;06;29 So by developing different instruments and scales that derive or predict something in might predict undiagnosed insomnia or anxiety, depression might predict of control of asthma, things of that nature. But there's typically surveys that have been validated through different types of behavioral science, a cognitive interviewing techniques, things of that nature, and then putting them out there. Right. And there's pros and there's observables, which are caregivers, right?   00;23;06;29 - 00;23;33;29 So someone caring for an adult relative, they're scales like that around caregiver burden, these sorts of things. And I'll tell you that the FDA has made a concerted effort to focus on patient focused drug development, and they've put these guidelines out there in terms of what they expect as websites companies are going through their clinical trial or clinical development programs.   00;23;34;00 - 00;24;01;17 Right. So I think that was a really great step to say not only open to this, we want it, we expect it. Right. So we've seen some of that, too. Now get your question. How do you do it right. Well, you can go with it. You charge it claims and look at information about the patient. But you also need to go directly to the patient and get their voice so you can do qualitative types of exercises.   00;24;02;04 - 00;24;22;21 For us at Oracle, I think this live of voices two trials where we go out to cohorts of patients who are eligible and we run through issue friendly terms the inclusion exclusion criteria. What do you think? Would you participate or not? What do we need to change here? And there's a whole bunch of other things to expose them to.   00;24;23;04 - 00;24;46;07 And then they tell us just no way, and this is impacting them. Phone calls of various clinical trials that our clients are working on, and they're taking it back to the EMA, the FDA, and say, here's the patient's voice and this is why we're making the decisions so that we're representing what these patients want in our trials. And often it's different.   00;24;46;23 - 00;25;13;08 So that that's one way We're also seeing more decentralized clinical trials. So over the past four years, with all the challenges of leaving one out and going to a site DCT decentralize, some trials have really accelerated in terms of the volume of trials. So so no longer just a patient have to drive an hour or 4 hours or however far to a site.   00;25;13;21 - 00;25;41;10 Now you bring the trial to them. You bring the phlebotomists to their house, you send them the wearable technologies or whatever it is they might need. So you're meeting the patients where they are so that you could increase participation and be more efficient, more productive, and really get it done in a better way. And the last thing I might mention is some natural history of disease registries.   00;25;41;21 - 00;26;07;25 These are registries that occur usually before the product goes into phase two or phase three clinical trial. And this is where you really start to understand what is the natural history of the disease. Most important, rare diseases where it could take years and years to get a count out in development compounded through or me to diagnose the patients.   00;26;08;04 - 00;26;33;01 And it takes too long to do that. So understanding the natural history of disease is critical. Right now we're running a global registry called Guardian, which is in Gauci Disease type two and Type three, and this registry is the Guardian Registry Registries one. We're collecting patient and caregiver information. We're actually developing a new approach and a new ops or so.   00;26;33;01 - 00;27;04;27 We'll have the patients voice. There are no products indicated for type two or Type three. So all the information is being fed back to the clients who have compounds in development for consideration in their clinical trials. And we're working with the International Gaucher Alliance, which is the global patient advocacy group on this registry. So it's a great partnership and it's getting that patient's voice, you know, where it needs to be, which is in the hands of of the compound development.   00;27;04;27 - 00;27;29;14 You mentioned A.I., you touched on that a little bit at AEI has certainly become part of the conversation, thinking about how it is or has the potential to impact therapeutic research and development. What, in your view, is and isn't overhyped about A.I. and the different stages of research and getting drugs to market so much? I make a lot of a lot of hype.   00;27;29;20 - 00;28;10;01 But also there's there's a lot of there's a lot of sizzle and there's a lot of sauce, right this. So you have to look for it and find it. So reading articles about organizations like Genentech and Janssen who are doing what's called Lab in the Loop, right. And a lot of a lot of life science, pharma companies and biotechs are doing this now where they're doing a and they're crossing their existing and other contacts with biological databases to uncover where might there be a match where some combination of a compound or multiple compounds could actually influence some disease?   00;28;10;01 - 00;28;47;05 Right. And then they tested they put it back in. So that's one area where we're seeing a lot of activity with with a for sure, critical trial designs, just looking at feasibility and protocol optimization and to understand where are the patients, how we are and how they're helping with patient recruitment. Where is indentify sites identifying the patients and incorporating dashboards back at the sites to help doctors identify and quickly recruit those eligible patients, or at least to have the conversations to see if they're interested.   00;28;47;14 - 00;29;28;22 Understand diversity of disease using various databases that have social determinants of health to make sure that we're diverse. Once the FDA is draft guidances, which which looked at everything from social determinants and ethnicity to co-morbidities, other demographics, transplantation, patients, etc., etc., etc. real world evidence teams are using it for their literature reviews. Unfortunately, sometimes they come across hallucinations or some false references, you know, show up and therefore you're always going to need this human collaboration to make sure your data is reliable.   00;29;29;03 - 00;29;55;07 And I'd say the last thing my head is pharmacovigilance, where we can go into existing databases, e charts, claims, both structured or unstructured notes, I should say, you know, and pull out information to identify patients who are having issues and report it in some sort of rapid or real time reporting and not wait. So out a major issue?   00;29;55;19 - 00;30;18;15 Well, since the listeners have been interested enough to still be listening, let's reward them by diving deeper into some of those specific technologies for clinical trials. What is Oracle's role in helping with randomization and trial supply management, which I think is also known as interact of response technology? Again, the work being done to that to get to therapeutic breakthroughs faster.   00;30;18;27 - 00;31;04;00 Yeah. Or TSM randomization, trial or supply management and ERP. It used to be called priority and now it's our TSM. This is an area where we've been playing for a long time. Continue to look at our tools for our clients so that they're able to do things that are quicker, faster, more efficiently. And certainly we've invested in a number of new people around the organization in our data product team, which is made up of some phenomenal engineers, you know, and they're investing we're investing significantly in our technologies to bring it to the next level and clients are responding appropriately, which is which is great.   00;31;04;03 - 00;31;30;08 And it's in a scenario where it's going to help clinical trials more quickly and more efficiently. So amazing things are happening. But, you know, I'm never satisfied. So I'm always curious about what the future could hold. I mean, we already touched on A.I., but what trends and technologies are you seeing out on the horizon that are most likely to bring us the kind of health care revolution that we think is possible?   00;31;31;11 - 00;31;55;06 Well, we've talked about some of them, this change in thinking culture for sure. Some of the policy and privacy types of things that we need to to get through. But this is what's not only on the horizon, but is here, right? It's here right now. I'm excited about the things that we're doing with Oracle Life Sciences to get there faster.   00;31;55;18 - 00;32;30;27 You're combining the data, our medical intelligence for our clients, just seeing it all in one place so that our customers are able to leverage it in a way, giving back to a future for physicians to close that gap between clinical research and clinical care. I think that's what I'm most excited about, I suppose. Oracle recently, very recently announced Oracle Health Data Intelligence, which is being called an open intelligence ecosystem or innovation.   00;32;31;09 - 00;32;57;21 Talk about what is that and how that helps life sciences. And researchers love to do so. So first of all, the Oracle Health Data Intelligence platform, it's open. It's open to anyone, meaning that anybody could tap into it, regardless of what industry, what part of the health care industry or working life sciences, whichever system, electronic health record system you're you're using.   00;32;58;06 - 00;33;32;24 So it's really flexible from that perspective that anybody can tap into it. And the data is research ready, meaning it's usable, right? We're form forming it, we're standardizing, and we're harmonizing it in a way that you can go and do the research that you need to do and get the insights and generate the evidence that you need. And this will help in such a tremendous way with the challenges that I mentioned earlier, breaking down silos, connecting disparate data sources, being structured and data that's now usable.   00;33;32;24 - 00;33;59;14 Right? That is that is not usable currently and it's in many formats. So customers will be able to or anyone really can tap into usable data sets from thousands of sources. So that's the other thing anyone can participate, contribute data. We're going to pull in data from a number of different places and again, turn that data into information and that information into insights and that insight those insights into evidence.   00;33;59;26 - 00;34;23;25 So and this will include longitudinal health data, real world data. I didn't define real world data, so real world data is basically any data that is not clinical trial data. It's in the real world, right? So you see that the care that's occurring within the physician's office or hospital that's not part of a clinical trial is considered real world data.   00;34;23;25 - 00;34;48;01 So that's longitudinal health data, electronic health records, patient registries, whether it's natural history or safety, product registries, all that is considered real world data. And all of that will be part of the health data intelligence platform. And this is an API driven ecosystem, which means anyone could access it. As I mentioned before, whether you use an Oracle clinical application or not.   00;34;48;27 - 00;35;16;18 And you can rest assured knowing it's running securely and safely on the Oracle Cloud infrastructure and as you know, OCI Oracle cloud infrastructure, not only is it safe and secure, but it's a military grade infrastructure and it's being used by the Department of Defense. So you could trust it is reliable, scalable, and it's getting the job done. And the health data intelligence platform, as you know, we have it, we're building it, improving.   00;35;16;18 - 00;35;36;17 This is really a big part of our future here in Oracle Life Sciences at Oracle and quite frankly, in the broader industry. Well, great. You know, I got my answers. Thanks for being our guest today, Michael. We'll be watching those, watching for those shifting mindsets and the changes coming to life sciences. Certainly, Oracle seems to be leading the way in that area.   00;35;36;28 - 00;35;53;25 If our listeners want to learn more, though, about what Oracle's initiatives are or if they want to get in touch with you, is there a way for them to do that? You know, first, my thanks for having me on. I really enjoyed the conversation and pretty good and a couple tough questions in there. So thank you for that to join it.   00;35;54;04 - 00;36;20;28 Everyone is welcome to go to my page and connect with me. I try to post relevant things on occasion. So Michael from set of enforcing the Oracle dot com and find the Oracle Health Sub page of the Oracle Life Sciences of the Explosive Alexa Science Stage Armageddon Sounds good. That got it. Thanks again, Michael. And to our listeners, we don't want you to miss any episodes of research and action.   00;36;20;28 - 00;36;49;01 So please subscribe to the show. And if you want to learn more about how Oracle can accelerate your own life sciences research, you can just go to Oracle dot com slash life dash sciences and we'll see you next time.

2024-04-12 Hosts Amir Kalali, MD and Jane Myles were joined by Stacey Adam, Vice President, Science Partnerships for the Foundation for National Institute of Health. She shared about her experiences with platform trials, DCT methods, and how they are working to drive innovation further for patients.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

For more information, visit DPHARMconference.com. 

Today's Post - https://bahnsen.co/49cizrs Greetings from Dallas, Texas where I am the next two days before then getting to Houston on Wednesday and then to the TBG offices in Austin and doing three events there for a couple of days before returning to NYC on Friday. Today's DCT is housing-heavy with plenty else in the mix to make it worth your time. Dividend Cafe looked further into the time-tested wisdom of dividend growth investing, the historical factors that involved over the past few decades, and the lay of the land in the years ahead. Links mentioned in this episode: TheDCToday.com DividendCafe.com TheBahnsenGroup.com

2024-02-23 Join hosts Jane Myles and Joe Dustin for a conversation with Noelle Gaskill (BMS) around site centric DCT approaches and how some key components could make a hybrid DCT successful in interventional oncology.

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions' white paper* on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity. This podcast episode features the following speakers: Jodi Daniel is a Managing Director of Crowell Health Solutions and also is a partner in Crowell's DC office, who leads the firm's Digital Health Practice. She previously spent 15 years at the Department of Health and Human Services (HHS). Cara Tenenbaum is a Consultant with Crowell Health Solutions, leads Strathmore Health, and has extensive experience in health policy and patient advocacy. She worked at the U.S. Food and Drug Administration (FDA) for six years. Ben Moscovitch leads Amazon Web Services (AWS) healthcare and life sciences public policy efforts and focuses on policy reforms to improve health data interoperability and clinical research. Devon Adams is a Senior Policy Analyst at the American Cancer Society Cancer Action Network, the nonpartisan advocacy affiliate of the American Cancer Society. He works on policy related to cancer research, device and drug development, precision medicine, and clinical trials. Noah Goodson, Ph.D. is the Principal of Strategy & Advisory at THREAD Research. He spends his day supporting pharmaceutical, biotech, and medical device companies in the design and execution of clinical trials. White Paper: https://www.crowell.com/a/web/vFgM2vJzbE4wsuVyJ5o1py/advancing-adoption-of-decentralized-clinical-trials-rationale-current-state-and-policy-recommendations.pdf  

Happy Valentine's Day! In this reposted episode, Winston Brady speaks with longtime DCT contributor Will Begley about the life of St. Valentine. St. Valentine is a holiday that many people celebrate but few people know why we do so. When did we start celebrating Valentine's Day? Who was St. Valentine? Why hearts? Was this holiday cooked up to sell cards and chocolate, or was there something real, true, and meaningful at the heart of Valentine's Day? In this episode, Will Begley makes some guesses about the origins of St. Valentine's Day, how Valentine's Day became a day of card-and-rose-giving, and the backstory behind a number of the different St. Valentine figures.

2024-02-09 Hosts Craig Lipset and Jane Myles were joined by Stephen Sundquist (3CTN) and Bianka Courcelle (HSJ) to discuss the PI site perspective and experiences in implementing a trial cluster involving a satellite site in supporting patient access. The specific clinical trial case illustrates how the CRAFT hybrid DCT approach was applied to support collaboration between the pediatric cancer centre and an adult centre in supporting an AYA patient on trial.A great conversation was had about how the CRAFT hybrid DCT Framework; why it was built, how it was constructed, and why it matters.Site Supervision Template: https://3ctn.ca/wp-content/uploads/2022/04/CRAFT-Site-Supervision-Plan_WM.pdfCRAFT Framework: https://3ctn.ca/for-researchers/craft/Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2024-02-02 Hosts Craig Lipset and Jane Myles were joined by Chunky Satija (Everest Group) for a discussion around mergers & acquisitions in the DCT space and what we may see on the horizon as the market evolves throughout the year.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Hyundai's N Division is just over a decade old, but it's already helping once-thriving segments. Once upon a time, the world was flooded with sporty compacts from automakers across the board, from Ford's Focus and Fiesta hot hatchbacks to the Nissan Sentra SE-R, and everything in between. Despite the sport compact herd thinning out, the folks at Hyundai jumped into the fray with a hopped-up Elantra. Dubbed the Elantra N, this sedan packs a 2.0-liter turbocharged I4 under the hood that sends 276 hp to the front wheels by way of a six-speed manual or an eight-speed automatic. On this episode of Quick Spin, host Wesley Wren hops behind the wheel of the 2023 Hyundai Elantra N and puts it through its paces. Wren takes you on a guided tour of the Elantra N and highlights some of his favorite features. Later in the show, Wren takes you along for a live drive review. Adding to the mix, Wren chats with Autoweek's Emmet White, who experienced the DCT variant of the Elantra N. The pair talk share their experiences, compare the Elantra N to the competition, and more. Closing the show, the pair break down what makes the Elantra N special.

Matt and Zack talk about their drive in the 2024 Mustang Dark Horse; how it compares to a Camaro SS 1LE; whether or not Ford can sell a Safari Mustang;   whether or not the GT350 should have had a DCT option; our experience  with the Prius Prime; and we answer Patreon questions.  Recorded November 29, 2023 Head to factormeals.com/tire50 and use code tire50 to get 50% off. Take the guesswork out of buying tickets with Gametime. Download the Gametime app, create an account, and use code SMOKINGTIRE for $20 off your first purchase. Terms apply. Go to PrizePicks.com/tire and use code tire for a first deposit match up to $100! Visit OmahaSteaks.com, take advantage of 50% off sitewide plus use promo code TIRE at checkout to get that EXTRA $30 OFF your order. Minimum order may be required. Use Off The Record! and ALWAYS fight your tickets! Enter code TST10 for a 10% discount on your first case on the Off The Record app, or go to http://www.offtherecord.com/TST. Want your question answered? Want to watch the live stream, get ad-free podcasts, or exclusive podcasts? Join our Patreon: https://www.patreon.com/thesmokingtirepodcast Tweet at us!https://www.Twitter.com/thesmokingtirehttps://www.Twitter.com/zackklapman Instagram:https://www.Instagram.com/thesmokingtirehttps://www.Instagram.com/therealzackklapman 

2022-06-24 Our hosts were joined by Julie Lin and Kim Hawkins (Sanofi), and Alexander Pastuszak (Contraline, previously Vault Health) to discuss whether or not the use of DCT methods has to be "all or nothing."Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-11-03 Join host Craig Lipset and special guest host Angela Radcliffe for a great session with Madeline Geday (Astellas) around the Business Case for DCTs.Hear how and why including the DCT model as part of protocol design supports organizations to find the right balance operationally and makes the patients' lives easierLearn about the wide range of factors that need to be considered when determining the risk vs the benefit to a studyDiscuss how to determine what will work in your organization by using a decision-making process that finds the right methodologies and technologies which are dependent on the therapeutic and patient populationFollow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Kurt Stein has over 25 years experience in business and technology issues. His company, DCT, specializes in finding businesses technology experts in IT, cybersecurity, AI and related items. We have a robust conversation regarding AI, it's status. growth, the fears, and yes, of course I raise the Ultron option.This show is part of the Spreaker Prime Network, if you are interested in advertising on this podcast, contact us at https://www.spreaker.com/show/4863095/advertisement

Edward Triebell, Commercial Executive Director for MRN Technologies, discusses the biggest digital trends in clinical research right now, how COVID-19 impacted the use of digital within sponsors and CROs, what the future of DCT services looks like, and much more.

Hello and welcome to Episode 184 of Front End Chatter, Britain's Bestest Biking Bodcast with him, Martin Fitz-Gibbons, and him, Simon Hargreaves – with thanks as ever to our patient and perfect partners Bennetts, the bike insurance specialisms, and BikeSocial.co.uk, the most informative and entertaining motorcycling website on the, er web. Is it still called the web?  Anyway, check out the offers, discounts and competitions available should you choose to become a BikeSocial Member (free to Bennetts customers, £60 a year if not) – seriously, if you're planning on spending a few quid this year on tyres, kit and accessories, chances are the shop you'll buy them from has a discount offer with Bennetts – so sign up, ya fool! Right, on with the show and today it's a bit of a FEC-sack Special because we're getting a bit behind with your emailed questions and queries – so it's all you today: • whose leathers are on the wall of a hotel near the Nürburgring? • great biking reassessments, such as Harley are technically advanced and Honda do think they can change gear better than you after all: with mandatory DCT and, now, Honda's Eclutch – another auto transmission. Honda really don't like manual gearboxes, do they?  • plus, Martin recalls having to reassess adventure bikes after it became clear they were taking over the world • how to regain a biking mojo • how will BMW's front collision warning cope with 'progressive' riding in traffic?  • best bike for long range commuting?  • is the SWC300 any good?  • do we grow out of modifying bikes? And much much more... Thanks for listening, please spread the word, please ring-fence a couple of dates in your diary – we have a FEC tour of Spain coming up in early June 2024, and a FEC tour of the Borders in late July 2024! YOU HAVE TO BE THERE! It's such a good time. Also – keep your emails coming in to: anything@frontendchatter.com @SimonHbikes @Mufga

The problem I found with endodontics was that the more you learn, the less you can cut corners, and the longer it ends up taking! I was keen to learn how to be more efficient with endodontics so I brought on Dr Omar Ikram to talk us through his sequencing and protocols for RCTS. Turn those challenging appointments into seamless, lunchtime-friendly successes. Follow @specialistendo on Instagram to keep up to date with Dr. Ikram's endo-endeavours! https://youtu.be/yHoiX4gijpQ Watch PDP163 on Youtube Need to Read it? Check out the Full Episode Transcript below! Download the EndoPrep app for access to: Online study guides Links to free webinars An MB2 guide An endodontic calculator tool And so much more! If you liked this episode, you will also like PDP133 - Pulpotomies for Irreversible Pulpitis? Did you know? You can get CPD from the Web App or Phone App and watch premium clinical videos, for less than a tax deductible Nando's per month? Click below for full episode transcript: Jaz's Introduction: When I qualified from dental school, I was really into restorative, but the part of restorative I was most into was actually endodontics. In fact, I actually did quite a lot of root canals when I was a dental student. Jaz's Introduction:And the funny story is that because of orthodontics, I actually lost vitality of my four lower incisors.I had root canals from specialists for all my lower four incisors. So I actually experienced root canal treatment as a patient while I was a dental student. And also having really inspirational tutor and someone called Dr. Stephen Godfrey at dental school meant that I was actually really looking at these postgraduate options for specializing in endodontics as one of my serious career considerations. I went on to win the Tom Pitt-Ford prize, which is given to like one student per dental school every year. And I also won like this runner up prize in the Julian Webber Harley Street prize. And I was basically about submitting a case. And I did an MTA case back when I was a DCT in Sheffield. That was pretty cool. Using a scope, learning how to do simple retreatments. So I was on the path to really consider endodontics. Now fast forward 10 years. And my favorite type of endodontics is the referral pad. Okay, I'm joking but I'm kind of not joking because it's not my favorite thing to do anymore. I do TMD, I do restorative, I do occlusal stuff, tooth wear, and I get a lot of joy from that. Root canals is low down in my pecking order and one of the reasons I'm so keen to refer to my specialist colleagues is how long it takes me and I'm thinking if this tooth is going to take two hours with me and it's going to take one hour and 15 minutes with the specialist and they'll probably do a better job than I will. Then it just makes sense to see a specialist, right? If the patient can afford it, great. And also, in terms of an hourly rate, like GDPs doing endodontics that are particularly tricky and pushing boundaries and spending longer on it, it just doesn't make sense as a financial point of view. Because if your patient is paying for your time, then they may end up paying you more than the endodontist. And that just is bizarre. That should never happen, right? So I'm more than happy to rely on my endodontic colleagues. The way that this ties in to the superstar guest that we have today, Dr. Omar Ikram, who I'm sure many of you know of. He's very prolific on social media. He puts out such good stuff to the world in terms of being helpful in our endodontic treatments. He's very giving with his time and knowledge. So it's a great pleasure to have on Dr. Omar Ikram today. And I was thinking, what could I ask him? There's so many different topics that we could ask him. There's some topics I've already covered on the show when it comes to endodontics. And I thought it'd be a really good one about how to make root canals more efficient.

KimberLee Heidmann is the Executive VP of Patient Experience and Customer Success at Scout Clinical, a third-party provider of patient services for clinical trial participants and their families. As a global partner of sponsors of trials, Scout oversees travel, visas, housing and accommodations, and patient payments. Working with underserved communities and patients with rare diseases, Scout removes barriers to participation in clinical trials and supports researchers in their care of patients and trial protocols. KimberLee elaborates, "Right now, the focus in clinical research is very much on diversity and inclusion and health equity. We're excited about that because we're passionate about that here at Scout. We're uniquely positioned to help the sponsors and the sites with those hard-to-reach patient populations. You're seeing a lot more in clinical research, especially in the rare disease space, where we're even looking at cross-border enrollment and bringing patients from underserved populations to areas where there are centers of excellence for treatment and clinical research." "Another thing that's burdensome that we've received a lot of feedback from clinical trial sites is the requirement to use a lot of different vendors and have access to different technology. Technology has been such a wonderful thing for the clinical trial industry, and we've brought so many wonderful things to the forefront in terms of wearable devices and diaries and the DCT model, where we're trying to relieve the burden of the patients to have to go to the clinical trial site. All of these things are wonderful, and they're excellent tools for clinical research." "But in some respects, they do add a burden to the researchers to have to, either as a sponsor or a CRO, manage all of those different aspects or for the clinical trial site to engage with all of these different tools. Then, if you carry that down into the patient, the patients and their families, participants and their families, a lot of times they are being introduced to this technology as well. Managing the full trial ecosystem can be very difficult for researchers and patients."  #ScoutClinical #ClinicalTrials #RareDiseases #PatientTravel #TrialRetention #TrialRecruitment scoutclinical.com Download the transcript here  

KimberLee Heidmann is the Executive VP of Patient Experience and Customer Success at Scout Clinical, a third-party provider of patient services for clinical trial participants and their families. As a global partner of sponsors of trials, Scout oversees travel, visas, housing and accommodations, and patient payments. Working with underserved communities and patients with rare diseases, Scout removes barriers to participation in clinical trials and supports researchers in their care of patients and trial protocols. KimberLee elaborates, "Right now, the focus in clinical research is very much on diversity and inclusion and health equity. We're excited about that because we're passionate about that here at Scout. We're uniquely positioned to help the sponsors and the sites with those hard-to-reach patient populations. You're seeing a lot more in clinical research, especially in the rare disease space, where we're even looking at cross-border enrollment and bringing patients from underserved populations to areas where there are centers of excellence for treatment and clinical research." "Another thing that's burdensome that we've received a lot of feedback from clinical trial sites is the requirement to use a lot of different vendors and have access to different technology. Technology has been such a wonderful thing for the clinical trial industry, and we've brought so many wonderful things to the forefront in terms of wearable devices and diaries and the DCT model, where we're trying to relieve the burden of the patients to have to go to the clinical trial site. All of these things are wonderful, and they're excellent tools for clinical research." "But in some respects, they do add a burden to the researchers to have to, either as a sponsor or a CRO, manage all of those different aspects or for the clinical trial site to engage with all of these different tools. Then, if you carry that down into the patient, the patients and their families, participants and their families, a lot of times they are being introduced to this technology as well. Managing the full trial ecosystem can be very difficult for researchers and patients."  #ScoutClinical #ClinicalTrials #RareDiseases #PatientTravel #TrialRetention #TrialRecruitment scoutclinical.com Listen to the podcast here  

ReferencesJC mentioned that the diagnostic accuracy of 24 hour urine collection increases with more collections! Metabolic evaluation of patients with recurrent idiopathic calcium nephrolithiasisWe didn't refer to a particular study on sodium intake and the 24 hour urine but this meta-analysis Comparison of 24‐hour urine and 24‐hour diet recall for estimating dietary sodium intake in populations: A systematic review and meta‐analysis - PMC 24‐hour diet recall underestimated population mean sodium intake.Anna looking up ace i and urinary sodium Effects of ACE inhibition on proximal tubule sodium transport | American Journal of Physiology-Renal PhysiologyThe original FENa paper by Espinel: The FeNa Test: Use in the Differential Diagnosis of Acute Renal Failure | JAMA | JAMA NetworkSchreir's replication and expansion of Espinel's data: Urinary diagnostic indices in acute renal failure: a prospective studyHere's a report from our own JC on the Diagnostic Utility of Serial Microscopic Examination of the Urinary Sediment in Acute Kidney Injury | American Society of NephrologyJC shared his journey regarding FENa and refers to his recent paper Concomitant Identification of Muddy Brown Granular Casts and Low Fractional Excretion of Urinary Sodium in AKIAnd Melanie's accompanying editorial Mind the Cast: FENa versus Microscopy in AKI : Kidney360 (with a great image from Samir Parikh)JC referenced this study from Schrier on FENa with a larger series: Urinary diagnostic indices in acute renal failure: a prospective study​​Nonoliguric Acute Renal Failure Associated with a Low Fractional Excretion of Sodium | Annals of Internal MedicineUrine sodium concentration to predict fluid responsiveness in oliguric ICU patients: a prospective multicenter observational study | Critical Care | Full TextA classic favorite: Acute renal success. The unexpected logic of oliguria in acute renal failure Marathon runners had granular casts in their urine without renal failure. Kidney Injury and Repair Biomarkers in Marathon RunnersCute piece from Rick Sterns on urine electrolytes! Managing electrolyte disorders: order a basic urine metabolic panelThe Urine Anion Gap: Common Misconceptions | American Society of NephrologyThe urine anion gap in context CJASNExcellent review from Halperin on urine chemistries (including some consideration of the TTKG): Use of Urine Electrolytes and Urine Osmolality in the Clinical Diagnosis of Fluid, Electrolytes, and Acid-Base Disorders - Kidney International ReportsRenal tubular acidosis (RTA): Recognize The Ammonium defect and pHorget the urine pH | SpringerLinkOutlineChapter 13- New part: Part 3, Physiologic approach to acid-base and electrolyte disorders - Do you remember the previous two parts? - Renal physiology - Regulation of water and electrolyte balance- Chapter 13: Meaning and application of urine chemistries - Measurement of urinary electrolyte concentrations, osmolality and pH helps diagnose some conditions - There are no fixed normal values - Kidney varies rate of excretion to match intake and endogenous production - Example: urine Na of 125/day can be normal if patient euvolemic on a normal diet, and wildly inappropriate in a patient who is volume depleted. - Urine chemistries are: - Useful - Simple - Widely available - Usually a random sample is adequate - 24-hour samples give additional context - Gives example of urinary potassium, with extra renal loss of K, urine K should be < 25, but if the patient has concurrent volume deficiency and urine output is only 500 mL, then urine K concentration can appropriately be as high as 40 mEq/L - Table 13-1 - Seems incomplete, see my notes on page 406 - What is Gravity ARF?- Sodium Excretion - Kidney varies Na to maintain effective circulating volume (I'd say volume homeostasis) - Urine Na affected by RAAS and ANP - Na concentration can be used to determine volume status - Urine Na < 20 is hypovolemia - Says it is especially helpful in determining the etiology of hyponatremia - Calls out SIADH and volume depletion - Used 40 mEq/L for SIADH - Also useful in AKI - Where differential is pre-renal vs ATN - In addition to urine Na (and FENa) look at urine osmolality - Again uses 40 mEq/l - Mentions FENa and urine osmolality - Urine Na can estimate dietary sodium intake - Suggests doing this during treatment of hypertension to assure dietary compliance - 24 hour urine Na is accurate with diuretics as long as the dose is stable and the drugs are chronic - Diuretics increase Na resorption in other segments of the tubule that are not affected by the diuretic - Points to increased AT2 induced proximal Na resorption and aldosterone induced DCT resoprtion - In HTN shoot for less than 100 mEq/Day - Urine Na useful in stones - Urine uric acid and urine Ca can cause stones and their handling is dependent on sodium - Low sodium diet can mask elevated excretion of these stone forming metabolites - 24-hour Na > 75 and should be enough sodium to avoid this pitfall - Pitfalls - Low urine sodium in bilateral renal artery stenosis or acute GN - High urine sodium with diuretics, aldo deficiency, advanced CKD - Altered water handling can also disrupt this - DI with 10 liters of urine and urine sodium excretion of 100 mEq is 10 mEq/L but in this case there is no volume deficiency - Opposite also important, a lot of water resorption can mask volume deficiency by jacking up the urine sodium - Advises you to use the FENa - THE FENA - < 1% dry - >2-3% ATN - It will fail with chronic effective volume depletion - Heart failure, cirrhosis, and burns - Suggests that tubular function will be preserved in those situations - Also with contrast, rhabdo, pigment nephropathy - Limitations - Dependent on the amount of Na filtered - Goes through the math of a normal person with GFR of 125/min and Na of 150 has filtered sodium of 27,000/day so if they eat 125-250 mEq their FENa will be 600-800 - Urine osm < plasma osm in face of hypernatremia indicates renal water loss due to lack of or resistance to ADH - In ATN urine OSM < 400 - In pre-renal disease it could be over 500 - Specific but not sensitive due to people with CKD who are unable to concentrate urine- Specific gravity - Plasma is 8-10% igher than plasma so specific gravity is 1.008 to 1.010 - Every 30-35 mOsm/L raises urine Osm of 0.001 - so 1.010 is 300-350 mOsm/L H2O - Glucose raises urine specific gravity more than osmolality - Same with contrast - Carbenicillin- pH - Normally varies with systemic acid-base status - PH should fall before 5.3 (usually below 5.0) with systemic metabolic acidosis - Above 5.3 in adults and 5.6 in children indicate RTA - PH goal 6.0-6.5 - Separate individual RTAs through FR of HCO3 at various serum HCO3 levels - Also can monitor urine pH to look for success in treating metabolic alkalosis - Look for pH > 7 - In treatment of uric acid stone disease - Want to shift eq: H + urate – uric acid to the left because urate is more soluble - PH goal 6.0-6.5

Ryan, Kevin and Gerard have a sit down with Sedrick Skabar for a quick chat about .... Being Sedrick. We touch on his past and present cars along with his journey into the DCT world . All that an more this episode For questions, comments or more info please visit www.serialnine.com

Welcome back to another exciting episode of Data Center Therapy, where the digital device management seas are stormy but the DCT deck crew are always ready for a challenge!  While Matt ‘Hard to Starboard' Cozzolino is out on PTO this week, your reliable and experienced Captain, Mr. Matt ‘Engines Steady at Quarter Impulse' Yette welcomes IVOXY End User Computing Consultants Mr. Ryan ‘Magnum VDI' Grelck and Mr. Aaron ‘Active Directory Animal' Hagman to the virtual DCT studios, for a chat about all things Microsoft Intune.       In this episode, you, our adventurous listeners, will get to hear about: What Microsoft 365 traditionally encompasses and how offerings beyond M365 integrate into the usual core technologies (Exchange, Sharepoint, OneDrive and Teams). How Microsoft Intune can be helpful for hybrid work and remote/travelling sales teams, and how SCCM relates. Mobile Device Management, including some old stories of MobileIron, and what Intune is capable of doing for the new corporate end user's experience and data management (including conditional access). How Azure Active Directory (now Entra) can integrate with on-premises infrastructure and clients and what happens when the Internet goes out.     After listening, if you're excited to join the September 19th through 21st Intune class (with Office Hours on September 22nd) then please be sure to reach out to your IVOXY Account Manager or podcasts@ivoxy.com so you can register yourself.  If you enjoyed this episode, please be sure to like, share and subscribe wherever quality podcasts like DCT are found.     Thanks as always for listening, and stay safe, get your (Windows) Autopilot on, stay (mobile) managed and catch you on the next fun and informative episode of Data Center Therapy!    

We are back with a bang Edward Colver!Colver was more than just a photographer; he was a witness to a cultural revolution, capturing pivotal moments that would shape music history forever. In this episode, we explore the unique path that led Colver from the peace and love of the hippy era to the raw energy, sometimes violent but always rebellious wolrd of LA hardcore.You can see more of Ed's work via his Instagram @EdwardColverGet your tickets for 2000 Trees and come hang early doors, 9am on the 7th July at the World Stage. Tickets via this linkThank you to Fidlar for not suing us and letting us use Cheap Beer as the podcast's opening track.Tracks played on the podcast in order of play:Wasted Youth - Teenage NarkThe Pretty Things - She's a LoverThe Deadbeats - Kill The HippiesDead Kennedys - California Uber AllesBad Brains - Banned in DCT.S.O.L - Abolish Government / Silent MajorityBlack Flag - Rise AboveFollow the podcast @punksinpubs across all social media and give us a rate and review while you are at it. Hosted on Acast. See acast.com/privacy for more information.

Hello, good morning and welcome to Front End Chatter, Britain's best general-purpose biking podcast (apart from racing podcasts, of which there are many and excellent). This is Episode 177 of nonsense, the first since the FEC Grin Up North tour. And it's been a while because Simon and Martin have been busy eking a living from the dry, dusty soil of freelance motorcycle journalism.  Thanks as always to Bennetts, with whom you ought to be insured for so many reasons – they're actually motorcyclists, for a start. And they support www.bikesocial.co.uk and its associated YouTube channel, where you can find road tests, launches, news, proper consumer advice and loads more genuinely useful, and entertaining, stuff. Check out becoming a BikeSocial Member, because the money-off offers alone are more than worthwhile – not to mention the competition offers.  Anyway, on this episode of FEC Simon and Martin natter about:  • The FEC800 Grin Up North Tour • Martin's impressions of Suzuki's GSX-S1000 GT+ • Simon's impressions of Honda's Gold Wing • Honda's DCT system and why it's taken 13 years for Simon to get over himself  • why Ireland is SO NICE! • speculation about BMW's M1000XR • some truths about the hydrogen as an alternative fuel, and why the Japanese manufacturers have got together to find out it's probably not the answer • your FEC Sack questions and queries including why changing your tyres is a Good Thing, why there's good riding in the south of England if you go looking for it, is Ducati's Monster defined by a trellis frame, and riding bikes before you were born. *From* before you were born, not actually pre-womb.  Thanks for listening, send your questions, thoughts and lunatic ravings to anything@frontendchatter.com Get me and Martin on the socials @simohbikes @Mufga  This episode is dedicated to the memory of Boz.