Clinical Trial Podcast | Conversations with Clinical Research Experts

Saudi Arabia's modern healthcare system, diverse patient population, and research-savvy healthcare professionals make it a great place to conduct clinical trials. To learn more about the clinical trial requirements in Saudi Arabia, I invited Professor Majed Al Jeraisy on the show.   Dr. Al Jeraisy is an Associate Professor of Pharmacy Practice, College of Pharmacy, King Saud Ben Abdulaziz University for Health Sciences and Pediatric Clinical Pharmacy Consultant in King Abdullah Specialized Children Hospital. He was appointed as the chairman of the research office at King Abdullah International Medical Research Center (KAIMRC) in 2007 and was appointed as the Director of Clinical Trial Services in 2018.  Please join me in welcoming Professor Majed Al Jeraisy on the Clinical Trial Podcast. This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/ This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com 

To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY.  He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device approval or indications in the US), has authored more than 3000 manuscripts and abstracts published in the peer-reviewed literature, and has delivered thousands of invited lectures around the world.  With an H-index of 202, Dr. Stone has been recognized in Nature Medicine as one of the most prolific authors in science, and by the Web of Science as among the top 0.01% of cited researchers in science.  Dr. Stone completed medical school at Johns Hopkins University Medical Center, in Baltimore, MD, and his internship and residency at the New York Hospital-Cornell Medical Center in New York City.  He completed his general cardiology fellowship at Cedars-Sinai Medical Center in Los Angeles, CA and subsequently a dedicated fellowship in advanced coronary angioplasty in Kansas City, MO.  Please join me in welcoming Dr. Gregg Stone on the Clinical Trial Podcast. Sponsor(s): This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more. Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space. Dan graduated from the Katie School of Insurance at Illinois State University where he studied Risk Management and Enjoy! Sponsor(s): This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/ This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit ​https://sites.veeva.com/​  

To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast.  Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs) Prior to joining Dexcom, Dr. Beck worked at Food and Drug Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molecular Genetics. Dr. Beck received her Ph.D. in Biomedical Science from the University of California San Diego, and her B.S. in Chemical Engineering from the University of Texas at Austin.  She also received her Master of Public Health (MPH) in Epidemiology from University of Maryland Baltimore.  Sponsor(s): This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/ This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit ​https://sites.veeva.com/​.

Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.  To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison​ ​Bateman​-​House​, ​PhD​, ​MPH, MA​, ​an​ ​Assistant​ ​Professor​ ​in​ ​the​ ​Division​ ​of​ ​Medical Ethics​ ​at​ ​NYU​ ​Grossman​ ​School​ ​of​ ​Medicine​.  Dr. ​Bateman​-​House​ ​is​ ​co​-​chair ​of​ ​the​ ​Working​ ​Group​ ​on Compassionate​ ​Use​ ​and​ ​Preapproval​ ​Access​ (​CUPA​), ​an​ ​academic group​ ​that​ ​studies​ ​ethical issues concerning access​ ​to​ ​investigational​ ​medical products​ ​and which consists of patient advocates, clinicians, members of industry, current and former FDA staffers, lawyers, and academics, among others.  She advises biopharmaceutical companies, patient advocacy organizations, governmental, and non-governmental entities about clinical trial design and non-trial access programs, and she serves as ethicist for numerous data safety monitoring boards overseeing clinical trials.  She has published and spoken extensively on non-trial access to investigational medical products, ​​equity in clinical​ ​trials​​, individualized therapeutics, ​the​ ​history​ ​and ethics​ ​of​ ​using​ ​humans​ ​as​ ​research​ ​subjects​, and public health ethics.  Sponsor(s): This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com  This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast. Erika advises life sciences, academic medical centers, hospitals, cancer centers, foundations and health systems process improvement initiatives for productivity, quality and efficiency in operations, cross-functional relationships, administration, manufacturing, and compliance.  She has over 20 years of research/ R&D experience, serving in roles such as Vice President Research, Senior Managing Director, Director Clinical Trials Office, Director of Clinical Research, Interim Executive Director, Clinical Trials Office and Director of Research Operations.  Erika holds her B.A. from the University of Vermont, her M.A. from Case Western Reserve University and her M.A. from Temple University.  She also holds a Graduate Certificate in Gerontology from Case Western University. Please join me in welcoming Erika on the show. Podcast Sponsor(s): This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Slope is trusted by industry leaders in complex early-phase clinical trials from top 50 pharma and CROs to emerging biotechs, and a global site network including NCI cancer centers and AMCs. Learn more at https://www.slopeclinical.com/ This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.  

To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast.  SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and facilitate the process by reducing barriers for sites and participants. Prior to the launch of SiteBridge, Chris has held various leadership roles at PPD, GlaxoSmithKline, Accenture and ZS Associates. Chris holds a B.S. in Systems Engineering from the University of Virginia and an MBA from Duke University and resides with his wife and three children in Chapel Hill, NC. Please join me in welcoming Chris on the Clinical Trial Podcast. Sponsors: This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at https://www.slopeclinical.com/ This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.  Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.  Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients contributed to research learning. JoAnne has served in the healthcare industry for almost 30 years. She leads Mercy Research, a not-for-profit organization managing clinical and real-world-evidence research activities across Mercy. JoAnne serves as current Chair and inaugural founder of Mercy Women in Leadership Council and as a member of Mercy's Diversity, Equity, Inclusion and Belonging Advisory Board. JoAnne received her undergraduate, law and master of business administration degrees — all with honors — from Washington University in St. Louis.  Please join me in welcoming JoAnne on the Clinical Trial Podcast.  This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com  

In this episode, we're going to talk about Postmarket Surveillance Studies.  In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.  The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device.  To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast. David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.  David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.  David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, and author of Mythical Medical™: Revelations from a Global Product Approval Consultant.  * This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com  This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/ *  

There are advantages and disadvantages when it comes to being a standalone clinical trial site.  Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.  This is where site networks come in.  For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network. To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show. Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.  Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.  With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian's companies have served patients and providers across thousands of research sites globally.  His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.  A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa. Enjoy! Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope's eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.   

In this episode, I'm excited for you to learn about Heart Failure Clinical Trials for medical devices. Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart. At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle. Sonna has extensive experience in the heart failure medical device space. Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more. In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more. Sonna is an effective communicator (as you'll soon find out after listening to this interview) and an amazing human being. I hope you enjoy my conversation with Sonna Patel-Raman.  Sponsors: This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I'm particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/. This podcast is brought to you by Slope. Slope's eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io. 

To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.  Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials. Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials.  She holds a B.S and M.S in Chemistry along with a Master's in Technical, Scientific, and Medical Communication.  Sponsor: This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/

This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose. You'll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. You'll also understand key terminology around risks, how to define risk, what's special about clinical studies with respect to risk management, and much more. Our guest today is Bijan Elahi. Bijan has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a technical fellow and Medtronic corporate advisor on safety risk management of. medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he also teaches a graduate course on medical device risk management at Drexel University in Philadelphia. Bijan is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 6,500 individuals worldwide. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices.  Last but not least, he is the author of Safety Risk Management for Medical Devices, published by Elsevier publishing. Enjoy! Sponsor: This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform.  To learn more, visit slope.io and ask to speak with a solutions coordinator today.

In this episode, I'm excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings.  Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs).  These meetings are exceptionally critical to the success of any medical product development. The purpose of these meetings is to discuss the clinical trial strategy, clinical investigational plan, patient enrollment initiatives, publication plan, and more. Although it entirely possible to conduct these meetings virtually (and sometimes you're better off conducting them virtually), the focus of this episode is on in-person meetings. But most meetings tend to poorly organized with lack of purpose and defined objectives i.e. what is it that you hope to achieve by conducting this meeting. If you're directly or in-directly involved in organizing a meeting with KOLs, this episode will serve you well. This episode is brought to you by Calyx. To learn more on how Calyx can help you with your medical imaging needs, please visit calyx.ai

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development.  I hope you enjoy this conversation with Dr. Oren Cohen. Podcast Sponsor: This podcast episode is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit calyx.ai   

Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients. Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges. To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network. Dr. Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world. In total, he has over 22 years of experience and has been involved with more than 200 first-in-human studies as well as over 2,000 studies across all areas of clinical pharmacology. After finishing his PhD in Neurology and Neurosurgery, Graham worked at MDS Pharma Services, Cetero Research, Manna Research and Altasciences as well as spending two years working at biotechnology companies. * This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. The Slope eCSCM platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by moving the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform.  To learn more, visit slope.io and ask to speak with a solutions coordinator today.  *

Medical Imaging in Clinical Trials with Elizabeth Dalton In this episode, I'm excited to talk about medical imaging in clinical trials.  We'll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more. The guest for today's show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.   Liz is a seasoned clinical trial professional with 17+ years of experience working with sponsors, sites, and CROs in centralized medical imaging and clinical trials. Driven by a passion for service, Liz's ethos is rooted in honesty, productivity, commitment, and the power of positive energy.  In addition to her primary role of growing the Calyx partnership/CRO channel, Liz leads a team of technical solution consultants and is a medical imaging consultant herself.  Liz attended the University of Massachusetts where she achieved dual Bachelor degrees in Anthropology and Economics (magna cum laude) and will graduate in May 2023 with her MBA from Boston University's Questrom School of Business.  Please join me in welcoming Liz on the Clinical Trial Podcast.  This episode is brought to you by Calyx. To learn more about Calyx, please visit https://www.calyx.ai/ 

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, I invited Darshan Kulkarni to the show. Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker. He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health. He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry.  Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise. Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry. This podcast is brought to you by Florence Healthcare. The learn more, please visit florencehc.com  

In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants.  In other words, the success rate was 21%. And the total funding amount was $8,827,444,624. The question I had was, “What does it take to get grant approval and launch an NIH funded research project?” To answer this question, I invited Dr. Manish Shah,  Professor of Pediatrics at Baylor College of Medicine and Attending Physician in the Texas Children's Hospital Emergency Center in Houston.  Dr. Shah has served on several national committees to advocate for improvements in pediatric and prehospital emergency care.  His research has focused on developing, implementing, and studying outcomes related to evidence-based protocols for various clinical conditions, including seizures.  Dr. Shah is currently the Principal Investigator for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study, which has been funded by the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted in the Pediatric Emergency Care Applied Research Network (PECARN). Please join me in welcoming Dr. Shah on the Clinical Trial Podcast.  This episode is brought you by Florence Healthcare. To learn more, please visit https://florencehc.com/

A big part of managing clinical research at any site is managing clinical research billing. If you don't keep track of your research finances, it can end up costing you a lot of money in the long run.  To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more,  I invited our guest, Kristi Etchberger, on the show.   Kristi founded Clinical Research Billing in 2015 to help independent research sites manage their CTMS and generate cash flow through invoicing and collections. After nearly seven years, she and her partners have built Clinical Research Billing into a successful, growing small business. Kristi served as Chief Executive Officer of Atlantic Clinical Research Collaborative in Palm Beach County, Florida, where she oversaw the implementation of a clinical trial management system.  Kristi is an experienced corporate executive with a background in corporate finance and international equity markets.  Kristi received her M.B.A. in finance from The Wharton School at the University of Pennsylvania, B.A. in economics and psychology from Pitzer College, Claremont, California, and the Chartered Financial Analyst designation from the CFA Institute.  She studied pharmaceutical law at Seton Hall University. Please join me in welcoming Kristi on the show. This poodast is brought to you by Florence Healthcare. To learn more, please visit https://florencehc.com/.  

As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for clinical research sites. It goes without saying you need a laptop and stable internet connection to do business in this day and age. But what else do you need to keep yourself organized as a clinical research site?  How can a clinical trial site bring most value to their research participants, run a profitable research operation, and not overwork employees with administrative tasks? To answer these questions and more, I invited Ryan Jones to join me on the show. If this is your first time listening to Ryan, I also invite you to check out my earlier interview with Ryan, Solving Clinical Research Problems Using Technology, episode #12, of the show. Aside from the technology discussion, I'm a huge fan of the company culture that Ryan and his leadership team at Florence Healthcare have created for their employees. We wrap up the episode with a couple of great book recommendations that you might be interested in reading. I hope you enjoy my conversation with Ryan Jones. Ryan Jones on LinkedIn and Twitter  Florence Healthcare on LinkedIn and Twitter

Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB.  Previously she served as senior vice president, research, at the Brigham and Women's Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research integrity.  She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH. In addition to her academic responsibilities, she currently serves on the Board of Directors of Vivli, Inc., a non-profit organization founded by the MRCT Center dedicated to global clinical trial sharing; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research.  Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), on the Board of Public Responsibility in Medicine and Research (PRIM&R), and as chair of the Secretary's Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 240 publications and has served on the editorial boards of a number of journals including Current Protocols of Immunology, Blood, Therapeutic Innovation and Regulatory Science, Ethics and Human Research. Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School. Please join me in welcoming Dr. Barbara Bierer on the Clinical Trial Podcast.  This episode is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

This podcast episode highlights the top reasons for patient recruitment failure in clinical trials from an investigator perspective.   The podcast episode will help you understand how Sponsor and CRO personnel including software vendors can best support investigators meet or exceed their patient recruitment.    The goal is to bring more awareness on how to prevent patient recruitment failure and complete enrollment as planned.   Initial funding insufficient to reimburse recruiting staff/sites Context-specific logistic obstacles (e.g., urgent transfers from intensive care, different treatment availabilities at different centers or on weekends) Lack of methodological/logistical support (e.g., from contract research organization or clinical trial unit) Prejudice against effectiveness of trial interventions  New evidence from other study about effectiveness of trial interventions Administrative burden/time constraints  Lack of eligible participants - Overestimated prevalence (mostly reported as overly narrow eligibility criteria) Concurrent competing trials High burden (e.g., many visits, invasive procedure, questionnaires, costs)  To learn more and get detailed show notes, visit clinicaltrialpodcast.com Podcast Sponsor: This episode is brought to you by Florence Healthcare. 

Clinical trials are conducted in compliance with regulations.  Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I've felt lost because I did not understand the regulatory framework. To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show. In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States. She does a great job of tailoring our conversation to make it applicable for clinical trial professionals. We cover topics such as working with the FDA, partnership between regulatory affairs and clinical research, career and professional development, and much more. The art and science of regulatory affairs is fascinating and there is no better person on the planet who can educate us on this topic. Please join me in welcoming Priya Jagasia on the Clinical Trial Podcast. Podcast Sponsor: This episode is brought to you by Florence Healthcare. To learn more, visit florencehc.com

The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed in the right direction.  The change in turn has led to an increased focus on decentralized clinical trials (DCTs).  But what exactly is a DCT?  To learn more, I invited Derk Arts, Founder & CEO of Castor.  Derk has over fifteen years of experience in medicine, research and technology.  His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials.  What is great about Derk is that he is a physician by training and now runs a clinical trial software company.  At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting.  At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems.  This was a fun interview for many reasons.  Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor’s company culture, his favorite books, honey bees, and much more.  I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast. This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/.  

My guest for this interview is Rebecca Matthews, Chief Clinical Operations Officer at Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation. In this interview, Rebecca shares with us what it takes to conduct clinical trials investigating the use of MDMA, a psychedelic drug, in conjunction with psychotherapy to treat patients with post traumatic stress disorder (PTSD). PTSD can occur after a person experiences a significant trauma, like a sexual assault, severe physical assault, significant threat to life arising from a hate crime, natural disaster, war, or accident. It affects people of all races, ages, and backgrounds.  As you’ll hear from Rebecca shortly, the clinical data from the recent clinical trial looks extremely promising.  This interview will leave you with excellent insights on differences and challenges of conducting research with psychedelic drugs including site selection, patient recruitment, clinical trial design considerations and more.  I am beyond excited to discuss this important topic of psychedelic research on the podcast.  Please join me in welcoming Rebecca Matthews on the Clinical Trial Podcast. Enjoy! Podcast Sponsor This interview you brought you Florence Healthcare. Transform your Clinical Trials with the #1 Platform for Electronic Document Workflows and Remote Site Access. Learn how Florence Healthcare helps over 7,200 research sites, sponsors, and CROs across 27 countries take their day back from paper.

Do you want to enroll a diverse patient population in your clinical trial?  Are you a sponsor looking to develop a solid clinical trial strategy? Are you looking to develop foundational skills as a clinical research scientist? If you answered “Yes” to any of these questions, then this interview with Jennifer Jones-McMeans will serve you well. Jenn currently serves as the Program Director for cardiovascular studies at Abbott Medical Devices.  She has played a key scientific role in some of the largest drug eluting stent clinical trials from trial design to publications and presentations.  It’s because of Jenn’s direct contributions as a scientist and scientific program director, many cardiology medical devices received FDA PMA approval or 510(K) clearance.  Most recently, Jenn has been involved in Abbott’s efforts in designing studies that include a diverse group of underserved clinical trial participants.  As an African American woman, mother, and wife, she is an inspiration and role model for women interested in developing their career in clinical research.  My interview with Jenn touches on a variety of topics including diversity and inclusion in clinical trials, developing a clinical trial strategy, working with key opinion leaders, skills you need to grow your career as a clinical scientist, and much more. I hope you enjoy my interview with Jennifer Jones-McMeans on the Clinical Trial Podcast.

One of the biggest challenges in clinical study start-up and conduct is “training.” A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more.  With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary. In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx. Joel shares with us how the ArcheMedx team is using technology and behavioral science to improve clinical trial operations with a focus on study training. We also discuss the importance of adequately preparing sites and site personnel to conduct a clinical study, how sponsors and CROs can effectively deliver study content and much more. I hope you enjoy my conversation with Joel Selzer on Clinical Trial Readiness.   

Many people tout about technical skills in clinical research. You need to know Microsoft Excel. You need to understand Good Clinical Practice. You need to memorize the FDA guidance documents. Have you ever heard someone talk about soft skills in clinical research? I realized the importance of soft skills after joining Abbott in 2007 as a Clinical Project Manager. When you work with a diverse team, you must master soft skills. Soft skills, also known as “real skills”, help you learn, adapt and grow.  In this interview, I invited Ed Hogan, Executive Vice President (EVP) at Invicro, to talk about soft skills in clinical research. Ed and I first met in 2005. He was the Director for Medical Imaging at PAREXEL/ Perceptive Informatics, my first job out of college. Ed is now responsible for overseeing the clinical services team which includes project management, imaging services, data management and reader management for early and late phase clinical trials. Ed has close to three decades of experience in clinical research, managing, and executing Phase I through Phase IV imaging trials in both the Pharmaceutical and CRO space.  He is THE expert when it comes to medical imaging operations. Ed has progressive business experience in building and managing global cross-functional teams supporting clinical trials focusing teams on delivery, accountability, and customer satisfaction while driving quality and process improvements. For these reasons, I invited Ed to talk to us about soft skills including negotiating contracts, how to develop a successful manager-employee relationship, what Ed looks for when he is wanting to promote someone on his team, leading effective meetings and much more.  I hope you enjoy my conversation with Ed to the Clinical Trial Podcast [3:50] Soft skills and project management [4:54] Negotiating contracts with Sponsor including cost, study design, and operations [7:25] Offer Sponsors what they need and not nice-to-have elements  [8:24] Clinical project managers are involved in finances   [10:22] Ideally Sponsor should ideally have a direct communication with imaging CRO [11:59] Example of risk mitigation in clinical trials  [13:39] Developing soft skills through PMP certification and courses and on the job training [14:45] Managing and working with project team members [17:21] Developing a strong team with diverse and complementary skills [19:01] Putting in time and practice to develop your skills [21:01] Soft skills are not easy to do [22:28] Key ingredients that make a successful manager-employee relationship [23:52] Giving direct and timely feedback  [25:37] Feedback “sandwich” [26:32]  Managers can plan and prepare before giving feedback. (a) State the outcome, (b) state the issue, (c) listen, (d) reinforce your intent to help, (e) repeat the end goal and expected outcome, (f) followup with an email [28:51] Practical advice on managing up [31:54] Giving and getting feedback from your colleagues  [34:06] Developing writing skills [36:01] Understand pain points to create winning proposals [37:23] Finance skills such as dealing with budgets, ability to write and communicate effectively, multitasking, time management, learning styles are some of the skills Ed focuses on when  promoting or hiring someone new [40:41] Getting your foot in the door with entry level clinical research roles  [45:54] Dealing with emotional employees when giving feedback    Resources Mentioned: Never Split the Difference with Chris Voss Project Management Professional (PMP) curriculum Radical Candor by Kim Scott StrengthsFinder 2.0 by Gallup (Author) The Five Dysfunctions of a Team: A Leadership Fable by Patrick Lencioni Myers Briggs Personality Test Official Microsoft Excel Video Training The 7 Habits of Highly Effective People by Stephen R. Covey Harvard Business Review for managers Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones by James Clear James Clear’s newsletter

In this episode, I had an opportunity to speak with Maha Dakhloul on the topic of Patient Support Programs (PSPs) in the Middle East and North Africa (MENA region). Maha does a great job of explaining with us how PSPs are set-up, how one can develop a PSP, the lesser known components of a PSP, how to measure a successful PSP, how to evaluate a PSP provider, the interdependence of clinical trials and PSPs in the MENA region and much more. This interview was recorded shortly after the explosion in Beirut in August 2020. I’d like to thank Maha for taking the time to chat even though her city was experiencing such pain. Maha has a bachelor’s degree from the Arab University of Beirut. She has worked as Clinical Research Coordinator, Clinical Research Associate, Regulatory Affairs Manager, Clinical Project Manager and is currently the Clinical Operations Manager at Phoenix Clinical Research . Please join me in welcoming Maha on the Clinical Trial Podcast. Maha Dakhloul on LinkedIn

Starting a career in clinical research with little or no experience can be difficult. Equally challenging is for hiring managers to find candidates that are a cultural fit for the organization. In this interview, I invited my close friend and mentor Chris Lewis to talk about his process of attracting, hiring, and retaining talent in clinical research.  We talked about the future of the CRA role and what skills are needed to succeed in today’s marketplace.   Chris has over 20 years’ experience leading teams and managing clinical trials in the medical device, biotech, and pharma industry.   At IntersectENT, he serves as Vice President, Clinical and is responsible for developing and managing clinical programs.   Chris graduated from the University of Louisiana, where he received his Bachelor's degree in Biology and an M.S. degree from George Washington University. During his spare time, Chris enjoys vacationing in our national parks with his family, trail running, camping, and pretty much every other outdoor activity under the sun. Please join me in welcoming Chris Lewis on the Clinical Trial Podcast.  Chris Lewis on LinkedIn Trainual software for onboarding and SOP training How to Win Friends and Influence People by Dale Carnegie Good to Great: Why Some Companies Make the Leap and Others Don't by Jim Collins Show notes: 1:52 Chris unconventional path to clinical research career  2:38 Journey from research coordinator to vice president  3:18 Impact of rise in technology, remote monitoring and risk based monitoring on the CRA’s role 5:49 Who is responsible for proctoring clinical trial cases? CRA or Field Clinical Engineer (FCE) 6:49 Importance of relationship management, technical expertise, problem solving skills and staying calm in the operating room   8:05 Building interpersonal skills through partnership and collaboration 9:34 Consolidation of electronic systems and access to sites  12:25 Process of hiring, interviewing and finding right talent 14:31 Leveraging social media (LinkedIn) and internal human resources systems for hiring 16:12 Getting to know someone through their hobbies, mannerisms, eager to learn, work hard, and ability to getting along with the rest of the team 18:03 The importance and process for having difficult conversations   22:53 Getting the new job posted  Creating clear job description Making a request for requisition Getting it approved through HR and executive 23:29 Making an offer Confirm with HR is the requisition is still valid  Obtain executive approval stage Clean communication between the candidate and hiring manager throughout the process  25:58 Onboarding new employees needs to be planned  Create an onboarding plan Clearly articulate and set expectations Training Plan Assign a mentor/ buddy (not their manager) Weekly meetings  Access to systems 28:34 Providing ongoing leadership and management  32:33 Core skills i.e. soft skills needed for a  clinical research professionals How to get along with people and see their viewpoints  How to manage a challenging situation 36:30 You don’t need two years of experience to get a job in clinical research  38:03 Getting into clinical research career with no experience Getting a masters degree in clinical research  Making contacts and exploring LinkedIn 39:19 How does living on the farm impact Chris’s life at work ? 41:00 Take control of your career, have patience, get your manager to understand your career aspirations Resources Mentioned Abbott Trianual - software solution for onboarding and SOPs [Book] The 7 Habits of Highly Effective People by Stephen Covey [Book] Good to Great by Jim Collins The Clinical Research Administration Program at George Washington University  

I’m always excited to speak with software entrepreneurs in clinical research and this episode is no excpetion. Our guest on today’s show is Maya Zlatanova, CEO of FindMeCure.  Maya and her team are creating a “google” for clinical trials.  She is on a mission to make it easy for patients to find ongoing clinical trials She wants to solve patient recruitment challenges enabling patients and doctors to connect with each other She believes in the power of stories, not just facts, something unheard of (but much needed) in clinical research. FindMeCure is dedicated to simplifying the patients' journey while volunteering for a clinical trial while helping the industry plan their trials with the full picture of country capacity, sites' experience and patients needs and journey. Maya is a healthtech entrepreneur, clinical research expert, and pharma industry speaker with over 15 years of global experience in clinical research regulations, patient recruitment, and engagement, clinical trial feasibility, and operations.  Maya’s strongest skill is empathy.  Her principles in life are to be trustworthy, care for other people and give first.  She also cherishes her never-ending curiosity about how life and the universe work, how to improve ourselves and our environment.  Please join me in welcoming Maya Zlatanova on the Clinical Trial Podcast. [2:25] About Maya’s company FindMeCure, Maya’s experience working on clinical research software for the British government and first online GCP training [4:14] Maya’s sister was diagnosed with an eating disorder and struggled to find treatment. This let to Maya looking at clinical trials from a patient perspective [6:06] Creating a global platform for patients to find out about alternative treatments in clinical trial setting [8:29] Connecting patients in one country with clinical trials in another country [9:55] Challenges for patients include: Human factors such as need to be close to family Traveling long distances to participate in clinical trials Being treated by different doctor (trial investigator) than their primary physician  [13:01] Patient recruitment process can benefit from change. Currently we first select sites and then bring patients into these sites [14:26] We need to break things to innovate [15:25] In an ideal world, we would have a centralized electronic health record, we know where patients are, patients are monitored with telehealth solutions, central site that is leading other sites  [16:55] Everyone wants to go to the experienced sites [19:43] Hybrid clinical trials [20:28] Need to support sites and investigators by questioning what sites should and shouldn’t do [24:05] convincing decision makers to select sites in other geographies using financial metrics [28:03] Language is not an obstacle at most sites. Ethical considerations can pose an issue.  CRO with local office  Site Management Organization (SMO) Own CRA networks [32:00] Adoption of technology in clinical research such as sites being open to new remote solutions [33:35] Whatever works for clinical research will work for the healthcare sector [34:03] ACRES helping sites getting accredited and certified if they follow certain standards for clinical trials [36:32] GCP is the only standard in clinical research. For example, it is not sufficient for patient centric trials [38:02] Need to align on initiatives such as patient engagement guidelines in EU and USA [39:45] Empathy is a feeling for people and imagining yourself in their shoes. Being open to the fact that you could be wrong. Listening to people, hearing you are wrong, and converting to the right thing [42:42] Maya’s secret weapon is speaking with different people with different backgrounds to learn and grow Resources mentioned: Society of Clinical Research Sites (SCRS) Association of Clinical Research Professionals (ACRP) Food and Drug Administration (FDA) Alliance for Clinical Research Excellence and Safety (ACRES) TransCelerate - Pharmaceutical Research and Development Pharmaceuticals and Medical Devices Agency (PMDA) EUPATI: Patient Engagement Through Education - EUPATI  

Clinical trial finance is a key area of clinical trials and clinical research.  Human beings are innately not good with numbers and clinical trial finance is no exception.  Creating study budgets, forecasting clinical trial costs, and managing trial finances are essential skills for any clinical research professional.  This is true for sites, vendors, CROs, and Sponsor personnel, irrespective of whether they have direct responsibility for clinical trial finances.  In this episode, I had the opportunity to speak with my friend Blake Peters who is exceptional at what he does with clinical trial finances.   Blake is currently an Associate Director, Clinical Research at Abbot Labs.   I’m excited to bring Blake on the show given his extensive experience managing multi-million dollar clinical trial budgets.  We had an excellent conversation on a variety of topics such as careers, being resourceful, clinical trial finance, storytelling and presentation skills, and much more.  I hope you enjoy this interview with Blake.  Blake Peters on LinkedIn. How does one make a transition into clinical research? Core skills Bringing value to your team Helping clinical project managers forecast and estimate clinical trial costs Excel skills Data analytics Financial mindset Continued curiosity to learn and grow Transitioning from finance to clinical research  Learning about the conduct of clinical trials Therapeutic knowledge On the job training A clinical research training conference Working with clinical project manager on finances  Challenging clinical trial assumptions to optimize financing Historic data on benchmarking Hospitals are required to publish procedure costs Collaboration with finance on clinical trials and research Alignment on vocabulary, a common understanding of what each if try to talk about Maslow’s Law of Hierarchy for Clinical Trial Costs  Cost of the clinical trial - a list of expense type Cost driver - how to multiply the expense, scales with sites and/or patients or fixed expenses Timing of these expenses  Factors that change the cost Total trial cost  Clinical Research Organization (CRO) budget - ensuring you are not overspending when you decide to outsource Review project management fees Review monitoring costs Categorize costs into buckets or functional costs (safety, data management, operations, etc.) Becoming proficient in Microsoft Excel  What do you find yourself doing manually and/or repeatedly? Be resourceful Spending 5-10 minutes can save you tens or hundreds of hours Research solutions (Youtube, Google) and implement Powerpoint skills in clinical research  Understanding the message Meeting with the stakeholders Think about table vs. graphs vs. graphics Don’t overdo animations First, get the content on the slide and then focus on the aesthetics of your slides Iterate, hit save and look at it again the next morning Types of PowerPoint slides Speak for itself with clean design Reference manual  Different audience/ use cases Slides are an outward representation of the person who built them. They serve as an opportunity to show your creativity and can open doors for you Valuable skills for clinical research professionals Listening Public speaking/ storytelling Passion and inspiration Managing stress with diet, meditation, drinking a lot of water  Resources mentioned: Abbott What Got You Here Won't Get You There: How Successful People Become Even More Successful by Marshall Goldsmith

Today we’re in the midst of the pandemic and virtual clinical trials are likely going to be a big part of our post-COVID-19 world.  In this interview, I had the pleasure of speaking with Mike Novotny about virtual trials i.e. decentralized trials.  Mike is the founder and CEO of Medrio. Mikes brings over 20 years of experience in research and software to his eClinical SaaS vision.  Prior to founding Medrio, Mike was president of Ninaza, an EDC software company, and had previously held roles as a research associate at the U.N. and a manager of the fraud database at VISA.  He holds a BA from Stanford University and an MBA from Columbia University. Mike founded Medrio in 2005 in San Francisco. I hope you enjoy my conversation with Mike. What is a decentralized or virtual clinical trial?  Benefits of a virtual clinical trial in patient recruitment The current model of clinical trials where recruitment is done through the doctor What does it mean to conduct a decentralized or virtual clinical trial? Case Study - CNS trials and how they can benefit from going virtual A limited number of patients (smaller patient pool)  Use of social media to find eligible patients The patient does not need to travel to the doctor’s office, the caregiver goes to the patients home Medrio as a technology provider for virtual studies  eConsent Electronic data capture (EDC) Direct Data Capture (DDC) Randomization with EDC  Case Study - Cholera vaccine study in Yemen Collecting clinical data without an internet connection The downside of paper data collection DDC is a subset of eSource eSource can be EHR, DDC, ePRO, eCOA Future of EDC as we get more integrated with EHR Patient recruitment New efforts through AI Efforts through social media Genetic profiling Enabling participants to be anywhere in the world to participate in the trial Barriers to adoption Importance of monitoring in a virtual clinical trial to prevent fraud  The downside of a virtual clinical trial is the implementation Patients want their doctor to be involved New tools lead to new complications The trial does not match the decentralized model Common concerns from Sponsors Storing data on the cloud is risky Offline data management - what if the wifi goes down or there is no cellular signal Data loss - what if the tablet break Thinking in terms of relative risk Clinical trials fail 90% of the time Trial data is never looked at again Need to standardize audits to bring the cost down and improving the quality of the audit Medrio is focused on:  Speed Great tool for early phase diagnostic and device studies Customer service measured using net promoter scores eSource - Direct Data Capture (DDC) Optimism, focusing on the positive, not watching/ reading the news

In this interview, I had the opportunity to speak with Ahmed Hamouda.  Ahmed is the Head of Clinical Operations at RAY-CRO in Egypt and a certified clinical research professional with more than 10 years of experience within the clinical research field. I’ve been intrigued and fascinated by the Middle East and have wondered how trials are conducted in the region.  If you’ve been site and country selection meetings trying to determine whether you want to conduct trials in Egypt but have more questions than answers, this interview is for you.  You’ll hear Ahmed breakdown the exact clinical trial conduct process in Egypt step-by-step. Ahmed has worked in a wide variety of professional capacities over different regions and markets in the Middle East, Gulf, Europe, and Asia. He is a pharmacist by education and received his MBA in 2013. Aside from being a clinical research professional, Ahmed likes to dive and explore new cultures. Show Notes: Ahmed Hamouda on LinkedIn Ahmed’s background and experience working in the Middle East  Value of conducting trials in the Middle East A large population of over 300 million people 21 countries in the region Prevalence of diseases such as cardiovascular and hypertension Reasons why some Sponsors and CROs are not doing research in Egypt Lack of awareness of Egypt’s capabilities  Long approval times for exporting blood samples  Importation process for medical products in Egypt Certificate of Analysis and quality documents Site Start-up Process Select sites Secure IRB approval (~1 month) Ministry of Health Approval i.e. MoH (~2 months) Observational trials can start right away Interventional trials require additional review (see below) Interventional trials (~2 months) Biological are submitted to The National Organization for Research and Control of Biologicals (NORCB) Non-biological are submitted to The National Organization for Drug Control and Research (NODCAR) Importing investigational medical product (IMP) Central Administration of Pharmaceutical Affairs (CAPA) Role of MoH vs. NORCB/ NORDCAR MoH will review study-specific documents such as protocol, eCRFs, CVS, patient-facing materials, insurance, patient diaries, signed contracts, etc. NORCD/ NODCAR will review information specific to the investigational product Process for adding more sites midway through the study Trial classification in Egypt - Phase I, II, III IRB rejections (decline) and how they are managed Product approval and commercialization  The concept around open-box vs. close box Pricing file is the limiting factor Naming list Pharmacovigilance (PV) files Contracts and Budgets Required at the time of IRB and/or MoH submission  Exceptions are handled via Sponsor/ CRO generated commitment letters Clinical Trial Research Units in Egypt  Allocation of budget and distribution between the site and the investigator Use of clinical trial contract templates  Contracts are in English and Arabic High-quality translations are achieved with the help of medically trained and certified translation company Site selection process  Lack of computerized system at the site can cause issues Career advancement for clinical research professionals in Egypt Social responsibility on part of CRO Other Resources: RAY CRO Pharma Med, a medical translation company ICH GCP Guidelines

Ravi Shankar is the founder of FCE Source, a boutique CRO that serves as a strategic partner to medical device companies looking for field clinical engineering support. FCE, which stands for Field Clinical Engineer, is a specialized role that specifically serves medical device trials.  FCE is a medical device expert who knows exactly how the medical product needs to be used in the medical setting. In many ways, an FCE is a right hand to the physician.  In this interview, Ravi does a fantastic job of sharing with us the roles and responsibilities of the FCE, what to expect from an FCE, how to get hired as an FCE and the skills needed to become a great FCE, common mistakes and challenges faced by FCEs, and much more. Please join me in welcoming Ravi to the Clinical Trial Podcast. Show Notes: FCE provides in-person product expertise in a medical device trial setting (medical device boots on the ground for a clinical trial) Difference between Field Clinical Engineer (FCE) and Clinical Research Associate (CRA) Can/ should sales representatives serve as FCE on a clinical study? History of FCE role and how it all got started in Cardiac Rythm Management (CRM) and pacemaker space  Education qualifications such as biomedical engineering needed to become an FCE FCE training involves observing in the operating room. You may react a certain way when watching a surgical procedure You need to work and learn independently as an FCE Studies are not designed keeping in mind the execution. You need to incorporate scientific, marketing, statistical and research coordinator perspective when designing trials FCE should not sell. They need to focus on research. Visual tools in the operating room (OR), study guide summarizing the protocol, and inclusion/ exclusion cards are helpful  How do you find out about job opening for FCE role Sponsors need to think of any additional ask as a trade-off with enrollment. Qualify your asks as minor, moderate, or significant FCE training would include observing cases, speaking up during cases, developing soft skills, experience with active implantable devices, direct patient interaction, and working in an operating room environment Not all FCEs are engineers FCE is not practicing medicine. FCE is a coach to physicians and other medical professionals FCE needs to be balance action versus learning  Salary for FCE is similar to entry-level engineering roles  

Using Medical Records to Pre-Qualify for Clinical Trials with Komathi Stem The traditional model involves sponsors and CROs contracting with trial sites and hoping the sites will find and enroll eligible patients.  Through her work at monARC Bio, Komathi Stem is flipping the traditional model upside down.  In this interview, Komathi shares how patients can now share medical records for clinical research purposes.  Pharmaceutical and medical device companies can then leverage this data to easily identify potential clinical research patients. With the rapid growth of software technology and high pressure to keep medical costs down, there is a growing need and application of real-world data in clinical research.  For this reason, we are likely to see a rapid use of technology and the use of real-world data in clinical research and trial management.  In this interview, we’ll cover the following topics: Why does monARC exists and what it does?  Data generated through routine clinical care and how to aggregate it Patient powered registries  Role of support groups, social media, clinician, and advocacy groups Mobile application to collect data between the clinical Understanding patient journey Geotargeting patients using Facebook Traditional versus “real-world” clinical trial Looking at the natural progression of the disease via a natural history study getting data on patients with no intervention Measuring treatment impact with a digital endpoint Impact of the intervention of Quality of Life (QoL) Challenges with real-world data  Access to the data Different formats and need for standardization Speed of decision making in big pharma Creating a sense of urgency using storytelling Importance of developing trusted relationships Future of electronic data capture (EDC) with the rise of real-world projects The current state of EDC and EHR integration Accelerating Research through Collaboration

In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research.  Throughout my career, I’ve always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand.  Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region. We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management. I hope you enjoy this energetic interview with Richard Stubbs.  [Show Notes] A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization New Zealand has the first world health system Investigator and industry-sponsored research in New Zealand  Ethics committee approval process  Organization’s mission is the education of clinical research site personnel (research coordinators, nurses, administrators) Conference every other year and then more frequent regional meetings Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template Schedule 6 in the contract allows sponsors to add additional verbiage in the contract Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019) Provisional approved and what it means Medical device approval in New Zealand and how it’s different from drug approval Regulations in New Zealand for Clinical Research Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies  Intellectual property protection No IND needed Fair budget Quick data Quality data Other regulatory bodies trust the data New Zealand is part of the Asia Pacific and Japan (APJ) region Site Selection in New Zealand  How to find sites What to consider Regulatory approval and site start-up processes in New Zealand Site start-up (gathering essential documents as governed by GCP) A centralized and electronic ethics approval process  Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND)  Role of the ethics committee in participant reimbursement  Payment to patients generally diminishes with the increase in the phase of the study Importance of embedding clinical research in clinical care Overhead costs at public and private hospitals in New Zealand Only make surplus money out of clinical research is the volume Thinking of clinical research in terms of value to patients and their staff Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses. Value systems in New Zeland such as men and women equality 

In this episode, I had the opportunity to speak with Antoinette Frankum, who currently serves as the Vice President/Executive Director of Clinical Research at CROMSOURCE, a global Clinical Research Organization (CRO). Antoinette has over 20 years’ experience leading teams and managing complex clinical trials in the biopharma and medical device industry.  At CROMSOURCE, she is part of the executive team responsible for the US and international clinical operations.  Antoinette graduated from University of California, Los Angeles (UCLA), where she received her Bachelor's degree and executive management certificate. In this interview, Antoinette and I talk about what it takes to be a successful clinical project management professional. You will learn about effective ways to communicate with senior leadership, how to conduct a brainstorming session, the importance of a “Lessons Learned” document and much more. We wrap up on a very topic of growth versus fixed mindset.  My advance apologies for the poor sound quality in the first half the interview but the content is still audible (and valuable). Hope you enjoy this interview with the all amazing Antoinette (Torres) Frankum. Show Notes: Antoinette (Torres) Frankum on LinkedIn Project Manager versus Program Manager: what is the difference?  Technical skill sets needed to become an effective clinical project management professional Creating and managing study timelines including tools such as Microsoft Gantt Understanding your stakeholders in clinical research Investigators Patients Regulatory authority Understanding your stakeholders in clinical research Managing patient expectations Managing resources and budget How to assess clinical trial risks as a CRO? Feasibility  Identify what is going to impact timeline, budget, resources Quality issues The right way to conduct a brainstorming session with your team Why you should conduct lessons learned during the close-out phase? Abundance thinking (growth mindset) versus scarcity thinking (fixed mindset) Helping your executive team by problem-solving Effective communication strategies with senior leadership Sites and CROs are on the same team It is okay to make mistakes Communication and people skills will help you grow faster Asking for feedback and ways to improve as a clinical research professional Books Mentioned: Mindset: The New Psychology of Success by Carol S. Dweck The Gifts of Imperfection: Let Go of Who You Think You're Supposed to Be and Embrace Who You Are by Brené Brown Rising Strong: How the Ability to Reset Transforms the Way We Live, Love, Parent, and Lead by Brené Brown

In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training. Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan. Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs). In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more. Please join me in welcome Jessie to the Clinical Trial Podcast. Show Notes: Getting into clinical research via technical roles such as data management and biometrics What makes a great statistician? Experience gained working for a big and small company Writing a statistical analysis plan Making CRO-Sponsor relationship work and how to succeed with outsourcing Getting unstuck - understanding how CROs and sponsors work Identifying clinical safety gaps and plugging in a CRO Protecting yourself as a sponsor when you outsource safety Working with CRO through iterations and why RACI may not work for you Outsourcing clinical events committee (CEC) and data safety committee (DMC) MEDRA coding: how it works, automation, generic versus specific coding Reducing CRO/ outsourcing budget and how to do it? Evolution of CRA role - drafting a protocol to writing reports Key Performance Indicators (KPIs) for a clinical research organization Turnover at a CRO and why it matters Financial KPI - money spent relative to the actions that were supposed to happen with that money Developing a process mindset - 5 major things that need to happen from beginning to end Evaluating employee performance relative to others Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on “hot” projects that delivered results   Volunteer yourself to get involved Moving beyond conference calls and emails - pick up the phone and talk to someone Clinical research is about working in a field where your work really matters  

Karmen Trzupek, MS, CGC, is part of the leadership team at Informed DNA where she is responsible for ocular and rare disease genetics services. In this phenomenal interview, Karmen shares with us the world of genetic testing and the role it plays in clinical trials. Karmen is a certified genetic counselor since 2005. She earned her masters in Genetic Counseling from Northwestern University and a bachelor’s in Microbiology from University of Illinois Prior to joining Informed DNA, Karmen was a genetic counselor and research assistant at Oregon Health & Sciences University. She has been a board member at the Hear See Hope Foundation and Usher Syndrome Coalition. Karmen is also a member of the National Society of Genetic Counselors, member and author of "NSGC Telegenetics Practice Guidelines" Working Group, member of the Association for Research in Vision and Ophthalmology, member and author of American Academy of Ophthalmology Clinical Working group to develop "Recommendations for the Clinical Assessment of Patients with Inherited Retinal Diseases" Her work has been published in GeneReviews; Current Opinion in Ophthalmology; Investigative Ophthalmology and Visual Science; Ophthalmic Genetics; Archives of Ophthalmology; and Ophthalmology Clinics of North America.Please join me in welcoming Karmen on the Clinical Trial Podcast. Topics discussed with Karmen: Evolution of genetic testing from one gene at a time to multiple genes at the same time Genetic testing in rare diseases such as inherited retinol diseases Cost of genetic testing Panel testing where multiple genes are tested at the same time How genetic tests are regulated Clinical trials in genetic testing and the benefits of genetic testing Role of a genetic counselor and how they work with patients, sponsors, patient foundations, and medical providers Recruitment challenges for sponsors for finding patients with rare diseases Use of telemedicine to expand access for patients Difference between genome and exome (whole) sequencing When is whole genome/ whole exome sequencing clinically relevant/necessary Our biggest challenge is trying to manage the volume of data Benign versus pathogenic variation in our genes What is Variant Interpretation crisis and Variant of uncertain significance (VUS)? Why insurance companies are willing to pay for genetic testing to determine the cause of the disease? Test the function of a particular genetic variance to: Identify patients Understand which patients qualify for gene therapy Very few drugs are approved for gene therapy for genetic diseases Antisense Oligonucleotide (ASO) Therapy How gene therapy is augmenting abnormal misfolded version of an amyloid RNA interference Therapy Precision medicine Difference between gene editing and gene therapy How does one become a genetic counselor? Why did we decide to start with gene therapy for retinal disease? Challenges with gene therapy Informed DNA team consist of genetic counselors primarily responsible for clinical, policy and consulting work Standards for panel testing

In this episode, I share with you strategies and tactical advice on patient recruitment. Patient recruitment is the foundation of any clinical study. If your trial doesn’t enroll the minimum number of patients required per protocol, you or your company cannot get the data you need to prove your trial hypothesis, determine product safety and effectiveness. More importantly, you cannot bring the medical product to the market on time (or possibly never!). This means loss of revenue and profits for the sponsor but more importantly, the patients that need your therapy won’t get it. In this podcast, I’m going to share with you 4 amazing strategies that will help you with patient recruitment. If you’re directly involved in a clinical study as a sponsor, CRO or even a site, this episode is a must-listen. If you’re creating a product or service for clinical research professionals, you need to ensure your work ultimately supports patient recruitment. Hope you enjoy listening to this solo episode by yours truly. This episode is brought to you by CBI Events. The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics. Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you. Some benefits from your participation in this event include: Learning strategies on how to ensure data integrity Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions Finding out about payer approval requirements and uncovering changing business models Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic And much, much, more. If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018. As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive. So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount. Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.

Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees. In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human research protection, ethical trial design, protocol development, development of ethical clinical research policy and practices and much more. Dr. McNair has more than 15 years of experience in clinical research and drug development strategy. She has designed and provided medical monitoring for Phase 1-4 clinical studies in a variety of therapeutic areas, including multiple oncology indications, hepatitis C, multiple inflammation indications (psoriasis, multiple sclerosis) and other areas. Dr. McNair is also an adjunct Assistant Professor at Boston University and teaches in the School of Public Health and in the Master’s of Clinical Investigation graduate programs, on the design and conduct of clinical research studies. She speaks frequently on the ethical conduct of clinical research studies as part of pharmaceutical drug development and improving interactions between ethics committees/ research review boards and the pharmaceutical industry. Dr. McNair graduated from the University Of Connecticut School Of Medicine and trained in general surgery at Boston University Medical Center. She has a Master’s in Public Health (Biostatistics/Epidemiology and Health Policy), and a Master’s of Science in Bioethics (research ethics). Please join me in welcoming Dr. Lindsay McNaire on the Clinical Trial Podcast. This episode is brought to you by CBI Events. The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics. Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you. Some benefits from your participation in this event include: Learning strategies on how to ensure data integrity Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions Finding out about payer approval requirements and uncovering changing business models Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic And much, much, more. If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018. As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive. So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount. Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.