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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 doc ...
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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, Colle…
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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…
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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 experienc…
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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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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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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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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 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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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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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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Ep. 4 Farina Pasta - Hellman’s Kitchen Veteran Foodie Podcast Learn about Army Veteran, Daniel Lee, and his “chipotle of pasta” business in Philly called Farina Pasta and Noodle. Dan worked as an EOD (Explosive Ordnance Disposal Specialist) in the Army for a few years, then went through culinary school using his VA G.I. Bill benefits. Support my sh…
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Ep. 3 Bad Company BBQ - Hellman’s Kitchen Veteran Foodie Podcast. Jason Betzing is a Coast Guard Veteran, who runs a small batch seasoning company and donates 100% of the profits to charity! He does all of this with his wife while traveling across the country in an RV the past 5 years. Support Jason’s veteran owned business at www.badcompanybbq.com…
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Ep. 2 Dax Snax - Hellman’s Kitchen Veteran Food Podcast. It was great hosting Dax Verdia, Marine Veteran and founder of Dax Snax, an all natural cookie company based out of New York selling locally. Dax is still in the Marines as a Reservist, and has a great story about how health & wellness lead him to creating a healthy alternative snack. Check h…
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Ep. 1 Bucket of Bread - Hellman’s Kitchen Veteran Foodie Podcast. This episode I talk to Chris Wysong, Army Veteran and Founder of Bucket of Bread, his premiere product is an organic gourmet dough mix ready to go for you in a bucket! Tune in to hear about Chris’s story as a vetpreneur. Check out Chris’s website, where you can buy your own Bucket of…
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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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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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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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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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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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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 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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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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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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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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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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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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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…
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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 woul…
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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 ove…
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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 trea…
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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 c…
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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 goi…
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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 P…
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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 …
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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 resear…
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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 recr…
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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,…
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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 softwar…
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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 i…
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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…
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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 patien…
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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 cli…
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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 indu…
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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 …
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