Podcasts about risk based monitoring

LINK TO ACRO'S RBQM SUMMARY REPORT: https://www.acrohealth.org/rbqm-summary-report/In this episode, ACRO RBQM Working Group members Lauren Garson (Veeva), Cris McDavid (Parexel), and Jennifer Stewart (Premier Research) joined ACRO's Good Clinical Podcast to discuss key takeaways from ACRO's annual RBM/RBQM Landscape Survey. Since 2019, ACRO's RBQM survey has dug into trial-level data on industry adoption of RBM and RBQM components. Informed by conversations with FDA, the aim of the survey is to evaluate ACRO member companies' adoption of risk-based monitoring to better understand how the larger framework of risk-based quality management (RBQM) are being adopted across the clinical trial industry.  

What does clinical trial monitoring have in common with growing a field of corn? Amy Kroeplin (PPD™ clinical research business of Thermo Fisher Scientific), Shailesh Madel (ICON plc), and Nicole Stansbury (Premier Research) join the podcast to discuss the importance of risk-based quality management, centralized monitoring, and strategic SDV/SDR sampling strategies. They dive deeper into the unique roles of SDV and SDR, different methods of implementing SDV/SDR sampling strategies, and the industry imperative to increase centralized monitoring adoption.

On this week's episode, host Sophia McLeod is joined by Danilo Branco (Associate Director, Risk Based Quality Management Lead, BeOne Medicines) and Amanda Coogan (Associate Director, Customer Experience, Remarque Systems) to discuss the value of centralized monitoring implementation by sharing case studies from today's clinical trials. They dive deeper into how centralized monitoring can help detect adverse events more quickly and identify underreporting, the benefits of holistically monitoring trial data using centralized monitoring, and how a targeted SDV/SDR sampling strategy can help organizations to conserve resources while maintaining quality and safety.

This week, ACRO's Good Clinical Podcast returns for a special episode! Lauren Garson (Veeva), Nicole Stansbury (Premier Research) and Jennifer Stewart (Premier Research) join the podcast to discuss the ACRO RBQM Working Group's latest paper, “Risk-based Quality Management: A Case for Centralized Monitoring," available to download at https://www.acrohealth.org/resource/rbqm-centralized-monitoring/They dive deeper into highlights from their latest publication, including the benefits of a risk-based approach to trial monitoring and the role that centralized monitoring can play in building more efficient and effective clinical trials.

Risk-Based Monitoring of Special Education Services: Performance Audit Services Manager Gina Brown recaps a new LLA report that examines the Louisiana Department of Education's risk-based monitoring of special education services provided to students with disabilities. | https://LLA.La.gov/go/podcast

Risk-Based Monitoring of Special Education Services: Performance Audit Services Manager Gina Brown recaps a new LLA report that examines the Louisiana Department of Education's risk-based monitoring of special education services provided to students with disabilities. | https://LLA.La.gov/go/podcast

How are organizations now tracking and assessing risk with risk-based quality management (RBQM) systems in the wake of new clinical trial designs and the COVDI-19 pandemic? That's one of the key questions explored during Linda Sullivan's interview with Duncan Hall, CEO and Founder at TRI — The Risk-Based Monitoring Company, which specializes in making RBQM simpler and more accessible.  Duncan, who appeared on CTO Episode #4 (August 2020), discusses how RBQM has been transformed and become more utilized in the last two decades, how the pandemic accelerated further RBQM changes, and how accompanying key risk indicator metrics have evolved as well. Duncan notes that the pandemic forced clinical trial managers to accelerate plans to implement RBQM through centralized monitoring. He also discusses how the broader adoption of DCT modalities, including the increasing use of wearables, will impact the design and implementation of risk-based monitoring.   Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com.

This week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk-based monitoring (RBM) approach may be the best method to support clinical studies while keeping an eye on compliance.   Resources from this episode: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Guidance for Industry (2013) A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers - Draft Guidance for Industry (2019) Tackling the Challenges of Transitioning to Risk-Based Monitoring   About Our Guest: Amanda Coogan, Senior Customer Partnership Manager, Remarque Systems Amanda spent the first 12 years of her clinical research career in clinical operations for university hospitals and medical device firms supporting domestic and international studies. She then transitioned to the software industry, where she has served for 6 years as a consultant, subject matter expert, and project manager to small and large pharma, medical device, and CRO customers supporting their implementation of Risk-Based Quality Management. In addition to working with customers to optimize their use of technology within their RBQM strategy, she provides clinical trial operation expertise to support software product development. She can be reached at acoogan@remarquesystems.com   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

#021 - The COVID-19 pandemic has affected so much including the clinical research industry. Have you wondered how this will affect monitoring as a Clinical Research Associate? During this episode, I will be talking with Jasmine Smith and I am so excited! She has over 6 years of clinical research experience and is a Senior CRA. Jasmine is knowledgeable with Risk Based Monitoring, 100% Source Data Verification, Unblinded, and Remote Monitoring. She is experienced with Phase II and III studies in the following therapeutic areas: Vaccines, Cardiovascular/Vascular Disease, Rare Disease, Gastroenterology, Endocrinology, Musculoskeletal, Pediatrics/Neonatology, Rheumatology, and Nephrology/Urology.Join us, as we discuss helpful travel tips and monitoring during COVID-19.

As Donald Trump announces he is the “Chosen One” and the Business Roundtable stuns the corporate community with a new Statement on the Purpose of Corporations, Tom and Jay are back  to discuss some of this week’s top compliance and ethics stories which caught their collective eyes. 1.    The Business Roundtable issues a new Statement on the Purpose of a Corporation. 2.    Mike Volkov takes a deep dive into the CCPA. 3.    Is Amazon liable for Capital One hack? 4.    Is summer the right time to close FCPA cases? 5.    You know it’s bad with BVI lawyer calls out the ABA for opposing UBO regulation. 6.    Proactive assessments in health care ethics and compliance programs. 7.    Trial judge rejects Alstom defendant 5thand 6thAmendment claims to toss case. 8.    UK goes after funds obtained through bribery and corruption. 9.    Monitor appointed in MTS FCPA enforcement action. 10. Sherlock Holmes is back in another week of Adventures in Compliance podcasts on the Compliance Podcast Network. Check out the following: Monday-The Three Garridebs and Monitoring Controls; Tuesday-The Problem at Thor Bridge and Monitoring Controls; Wednesday-theCreeping Man and Risk Management by Your Board; Thursday-The Lion’s Mane and Risk-Based Monitoring; and Friday-the Veiled Lodger and Empathy in Compliance. The podcast is available on multiple sites: the FCPA Compliance Report, iTunes, JDSupra, Megaphone,YouTube,  Spotifyand Corporate Compliance Insights,  Compliance Podcast Networkand now on the C-Suite Radio Network. 11. Join Tom and Jay and a host of other great speakers and guest at Converge19 in Denver October 2 & 3. Listeners to this podcast can obtain a complimentary ticket by using the promotion code foxvip, for registration and information, click here.  Tom Fox is the Compliance Evangelist and can be reached at tfox@tfoxlaw.com. Jay        Rosen is Mr. Monitor and can be reached at jrosen@affiliatedmonitors.com. For more information on how an independent monitor can help improve your      company’s ethics and compliance program, visit our sponsor Affiliated Monitors         at www.affiliatedmonitors.com.  Learn more about your ad choices. Visit megaphone.fm/adchoices

Welcome back to another episode of Adventures in Compliance. This week, we are considering stories from The Casebook of Sherlock Holmes, mining each story for themes and lessons related to the compliance professional, leadership and business ethics. Today, we  The Lion’s Mane. This is one of two stories narrated by Holmes himself and not reported by Dr. Watson. The final problem solved informs today’s discussion that it is risk-based monitoring which allows a person (or company) to operate safely so that no injury occurs. Yesterday, I considered The Creeping Man as an introduction to risk management and compliance at the very top of an organization. Today I want to discuss risk-based monitoring. Compliance Takeaways What is Risk-based monitoring?It is really about continuous, ongoing monitoring for those things which provide the most potential future risk to you. By using risk-based monitoring to review issues on an ongoing basis, and the models that are behind the risk-based modeling, risk-based monitoring models, they’re continuously refined based on incoming data.Siloed Data.The problem for many companies is they are siloed in not only their data but also in the systems. Because of the disparity of data systems, many companies are not tracking rigorous, quantified information all the time. As data comes in you begin to note certain patterns, which might actually point towards a variety of red flags for more thorough investigation.See issues in real-time?Having access to information around sales, the sales process and corporate largess in areas from corporate social responsibility work, to gifts, travel and entertainment, to conferences for customers and end users. With such risked-based monitoring a compliance professional has the opportunity see trends developing which could allow an intervention for a prescriptive solution which could prevent an issue from becoming a Foreign Corrupt Practices Act (FCPA) violation.Greater Profitability.Finally, the beauty of all these techniques is that they are tools that can make companies more efficient and, at the end of the day, more profitable. They also move compliance into the fabric and DNA of an organization or to use another well-worn phrase, operationalize compliance. The Department of Justice has made clear what it expects around the risk management process. You need to develop your response now.Join us tomorrow as we mine the story of The Veiled Lodger for its compliance lessons.

Risk-based monitoring plays an increasingly important role for clinical trials. Of course, the assessment of the risk is based on statistics. This presents now only interesting career options for statisticians, but also has an impact on the role of statisticians in study teams. In this episode, we'll give you an introduction to risk-based monitoring (RBM) as well as speak about the role of statisticians in this area. Further we provide you as a study statistician insights into what you need to know about RBM. Finally, we also give some recommendations in terms of further resources to learn from.

Congratulations to Medidata for winning this award. Medidata is a company that is well known in the clinical research sphere because of their solutions for entering data and clinical trial management systems. Ever since Risk Based Monitoring has become in the forefront since the ICH GCP R2 guidelines were implemented in the end of 2016, Medidata has been working on their solution to better implement Risk Based Monitoring. They have won this award for the past three years and we can definitely see why. Don't forget to Subscribe for new content! Email: eliteclinicalgroup@gmail.com Podcast: https://anchor.fm/clinical-research-p... Steemit: https://steemit.com/@ecrgmedia Watch: » Industry News: https://goo.gl/fNXpQ5 » All Videos: https://goo.gl/87XEFW » Interview Recaps: https://goo.gl/wJsk6W » Glassdoor Reviews: https://goo.gl/AbQzqe --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/clinical-research-podcast/message Support this podcast: https://anchor.fm/clinical-research-podcast/support

In this Part III to a three part podcast series, I visit with noted risk management expert, Ben Locwin on risk-based monitoring as a adjunct to forecasting and risk assessments. We discuss how to accomplish it and how to integrate into your overall monitoring and feedback loops. We conclude with a stitching together of the risk management process. For More Information see my five part blog series on the Risk Management Process.  1. Forecasting 2. Risk Assessments 3. Risk-Based Monitoring 4. White Noise and Interpreting Data 5. What does it all mean?   Learn more about your ad choices. Visit megaphone.fm/adchoices

Since the FDA and EMA published their current thinking on clinical oversight and risk-based monitoring (RBM) strategies, the topic has received a magnitude of attention, commanding column inches, webinar discussions and industry conferences. With so much discussion going on, it is unsurprising that many sponsors are feeling out in the cold when it comes to identifying how to practically implement RBM strategies within study designs. As data quality matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for solutions that simplify the transition to risk-based techniques. In this program, our guests discuss how emerging technologies and Central Statistical Monitoring (CSM) now present more practical means of implementing successful RBM strategies. Both Sanofi and Novartis will provide a large pharma perspective on making the move to RBM. Host: Valerie Bowling, Executive Director, The Conference Forum Guests: Marc Buyse, Founder, International Drug Development Institute & CluePoints Eric Genevois-Marlin, VP, Biostatistics & Programming, Sanofi Thomas Haag, Data Integrity Process Expert, eClinical Quality Assurance, Novartis Pharmaceuticals    

In this episode, Mr. Penniston and Ms. Taber talk about risk-based monitoring what it is, why it's important, what are the components, what skill sets or tools are necessary, and the challenges and opportunities related to risk-based monitoring.Thought Leaders: Mark Penniston, Senior Vice President and General Manager, Clinical Analytics, Theorem Clinical Research and Alison Taber, Vice President of Global Data Management, Theorem Clinical ResearchPlay podcast