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 doc ...
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The Indian Wedding Podcast show aims to introduce brides, grooms and their families to exceptional people in the Indian Wedding industry. You will hear leading experts in the Indian Wedding industry who can help you design and execute a dream wedding. You will be inspired by how you to make your wedding unique and meaningful. You'll receive insider tips on photography, wedding planning, catering, jewelry, wardrobe, and much more. No promotions - just value. All our guests are handpicked base ...
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How a Wedding Planner Can Save You Time Money with Vidhi Kshatriya
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Are you unsure whether you need a wedding planner? Will hiring one be an extra expense, or could it actually help you save time and money? In this insightful podcast episode, we delve into what it truly means to work with a wedding planner and explore the invaluable support they can provide. Our guest today is Vidhi Kshtritye, the founder of The Ma…
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Should you Hire a Bridal Stylist? Expert Advice with Tina Bhardwaj
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Have you ever wondered what goes on behind the scenes when you see a picture-perfect, beautifully styled wedding? If so, you’re going to love this interview because we’ll be meeting with a stylist who has years of education and experience styling for events, including weddings. Our guest today is Tina Bhardwaj, a certified fashion designer, wardrob…
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Diabetes Clinical Trials with Dr. Stayce Beck
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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…
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Achieve Unforgettable Wedding Videos with Arina Balerina
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Welcome to the Indian Wedding Podcast with your hosts Kunal and Jinal Sampat. In this podcast, we share insider tips for a magical wedding. Arina Balerina, CEO and Videographer of Balerina Films. Arina and her team have been featured in leading fashion and wedding magazines like Vogue, Over the Moon, and many more. Most importantly, her work speaks…
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Access to Novel Medical Products with Dr. Alison Bateman-House
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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 Gross…
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Clinical Research as a Profession with Erika Stevens
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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 pod…
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Community Engagement in Clinical Trials with Chris Komelasky
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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…
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Community health system-based research with JoAnne Levy
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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, co…
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Postmarket Surveillance Studies with David Rutledge
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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 yea…
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Human-centered design role in clinical trials with Bruce Hellman and Ben James
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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. eP…
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Clinical Trial Site Networks with Christian Burns
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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 campa…
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Heart Failure Clinical Trials with Sonna Patel-Raman
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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 …
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Medical Imaging for Clinical Trial Sites with Kelie Luby
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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 passiona…
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Risk Management for Clinical Investigators with Bijan Elahi
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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 le…
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5 Strategies for Investigator and Steering Committee Meetings with Kunal Sampat
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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 …
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Clinical Trial Outsourcing with Anca Copaescu
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Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
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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…
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Patient Recruitment in Phase I Studies with Dr. Graham Wood
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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 i…
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Medical Imaging in Clinical Trials with Elizabeth Dalton
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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,…
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Clinical Research Data Transparency with Darshan Kulkarni
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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, …
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Launching an NIH Funded Study with Dr. Manish Shah
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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 i…
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Introduction to Coverage Analysis with Kelly Willenberg
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Clinical Data Management with Mariam Mirgoli
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Oleh Kunal Sampat
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Clinical Research Billing for Small to Medium Sites with Kristi Etchberger
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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…
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Integrating EHR and EDC Systems with Hugh Levaux
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Software Solutions for Clinical Research Sites with Ryan Jones
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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 sit…
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Indian Pakistani Vegan Wedding with Heer Parikh
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In this episode, we explore what it takes to plan an Indian-Pakistani vegan wedding. Veganism is not a trend or fad. It is here to stay. There are couples who do not want to consume animal products for ethical and health reasons. These couples are bringing their love and passion for vegan lifestyle to their weddings. To learn more about vegan weddi…
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Diversity, Inclusion, and Equity in Clinical Research with Barbara Bierer, M.D.
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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 a…
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