Clinical Trial Podcast | Conversations with Clinical Research Experts

Kunal Sampat | Educator
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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/

  1. Inspection Readiness with Donna Dorozinsky

    10月12日

    Inspection Readiness with Donna Dorozinsky

    Clinical Trial Podcast | Conversations with Clinical Research Experts

    51 分鐘

  2. 5月31日

    Clinical Trials in Saudi Arabia with Dr. Majed Al Jeraisy

    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

    1 小時 16 分鐘
  3. Cardiology Clinical Trials with Dr. Gregg Stone

    2024/07/31

    Cardiology Clinical Trials with Dr. Gregg Stone

    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

    1 小時 9 分鐘
  4. Clinical Trial Insurance with Dan Fuld

    2024/07/14

    Clinical Trial Insurance with Dan Fuld

    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/​

    48 分鐘

  5. 2024/02/29

    Diabetes Clinical Trials with Dr. Stayce Beck

    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/​.

    51 分鐘
  6. Access to Novel Medical Products with Dr. Alison Bateman-House

    2023/11/05

    Access to Novel Medical Products with Dr. Alison Bateman-House

    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/

    1 小時 14 分鐘
  7. Clinical Research as a Profession with Erika Stevens

    2023/08/24

    Clinical Research as a Profession with Erika Stevens

    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/.

    1 小時 29 分鐘
  8. Community Engagement in Clinical Trials with Chris Komelasky

    2023/08/07

    Community Engagement in Clinical Trials with Chris Komelasky

    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/.

    1 小時 21 分鐘
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簡介

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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