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Kandungan disediakan oleh Kunal Sampat and Kunal Sampat | Educator. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Kunal Sampat and Kunal Sampat | Educator atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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Manage series 3560084
Kandungan disediakan oleh Kunal Sampat and Kunal Sampat | Educator. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Kunal Sampat and Kunal Sampat | Educator atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals. To learn more, visit https://clinicaltrialpodcast.com/
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64 episod
Tandakan semua sebagai (belum) dimainkan
Manage series 3560084
Kandungan disediakan oleh Kunal Sampat and Kunal Sampat | Educator. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Kunal Sampat and Kunal Sampat | Educator atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doctors, safety monitors, clinical scientists and other healthcare professionals. To learn more, visit https://clinicaltrialpodcast.com/
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64 episod
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Cardiology Clinical Trials with Dr. Gregg Stone 1:09:14
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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…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Clinical Trial Insurance with Dan Fuld 47:38
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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/…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Diabetes Clinical Trials with Dr. Stayce Beck 17:26
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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/ .…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
![Clinical Trial Podcast | Conversations with Clinical Research Experts podcast artwork](/static/images/64pixel.png)
1 Access to Novel Medical Products with Dr. Alison Bateman-House 1:13:43
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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/…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
![Clinical Trial Podcast | Conversations with Clinical Research Experts podcast artwork](/static/images/64pixel.png)
1 Clinical Research as a Profession with Erika Stevens 1:28:35
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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/ .…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
![Clinical Trial Podcast | Conversations with Clinical Research Experts podcast artwork](/static/images/64pixel.png)
1 Community Engagement in Clinical Trials with Chris Komelasky 1:20:33
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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/ .…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
![Clinical Trial Podcast | Conversations with Clinical Research Experts podcast artwork](/static/images/64pixel.png)
1 Community health system-based research with JoAnne Levy 1:32:40
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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…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
![Clinical Trial Podcast | Conversations with Clinical Research Experts podcast artwork](/static/images/64pixel.png)
1 Postmarket Surveillance Studies with David Rutledge 1:21:02
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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/ *…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Human-centered design role in clinical trials with Bruce Hellman and Ben James 1:21:21
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In this episode, we explore the role of design in clinical trials. Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements. To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical Trial Podcast. Ben is the Chief Design Officer and Co-founder at uMotif. Bruce is the Chief Patient Officer & Co-Founder at uMotif. Please join me in welcoming Bruce and Ben 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 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 *…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Clinical Trial Site Networks with Christian Burns 1:28:50
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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 .…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Medical Imaging for Clinical Trial Sites with Kelie Luby 1:22:19
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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/…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Risk Management for Clinical Investigators with Bijan Elahi 1:05:00
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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.…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
![Clinical Trial Podcast | Conversations with Clinical Research Experts podcast artwork](/static/images/64pixel.png)
1 5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat 34:49
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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…
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Clinical Trial Outsourcing with Anca Copaescu 1:00:10
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Clinical Trial Podcast | Conversations with Clinical Research Experts
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1 Complexity in Early Phase Clinical Trials with Dr. Oren Cohen 1:20:24
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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…
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