Hi Reader In this episode, I’m excited to share with you my interview with Erike Stevens discussing Clinical Research as a Profession. 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 Erika Stevens on the podcast. Erika...
about 2 months ago • 3 min read
Hi Reader If you’re a new subscriber, welcome! My name is Kunal Sampat, and I host the Clinical Trial Podcast. I also write blog posts on clinical research and am committed to sharing everything I know about clinical trials with you. If you’ve been on my email list for a while, thank you for your patience. My email updates have been less frequent than I’d like, but I’m excited to be back with regular content. In this episode, I’m excited to share an interview with Chris Komelasky on Community...
2 months ago • 4 min read
Hi Reader, This week, I'm excited to share with you another episode on the Clinical Trial Podcast. The guest on the show is JoAnne Levy, J.D., Vice President at Mercy Research, a part of Mercy Health. I loved this conversation so much because we spend the first 30 minutes discussing how JoAnne got started with clinical research. It was inspiring to hear JoAnne's story as a woman leader. There is A LOT to learn from JoAnne's transition from employment and environmental law to Vice President of...
11 months ago • 3 min read
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. 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...
12 months ago • 3 min read
Hi Reader I've not been able to prioritize the podcast until recently. Last month, I recorded 4 interviews and I cannot wait to share them with you. In this episode, we will explore the role of design in clinical trials, with a focus on electronic Patient Reported Outcome (ePROs). Most clinical research professionals are so focused on protocol development, data collection, and analysis, that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One...
about 1 year ago • 3 min read
Hi Reader In this episode, you’ll learn about the world of Clinical Trial Site Networks. 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,...
almost 2 years ago • 3 min read
Hi Reader Cardiovascular disease (CVD) is one of the top four leading causes of death. According to Heart Failure Society of America (HFSA), nearly 6.5 million Americans over the age of 20 have heart failure. To learn more about the topic of Heart Failure Clinical Trials, I invited Sonna Patel-Raman on the show. In this interview, Sonna provides us with an introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational...
almost 2 years ago • 3 min read
Hi Reader Clinical trial data comes in many forms including medical images. Medical imaging modalities include CT, MRI, PET, ultrasound, DEXA, angiogram, and more. The question that often comes up is, "How can Investigators make use of the imaging data to drive treatment decisions for trial participants in the most effective and efficient manner?" To learn about the role of medical imaging and related software in clinical trials, I invited my long time friend Kelie (Luby) Williams on the...
almost 2 years ago • 2 min read
Hi Reader A lot of of what happens in medical product development is managing risks. There is risk in every step of the medical product development lifecycle. Our guest today is Bijan Elahi, where we talk about risk management for clinical investigators conducting medical device clinical trials. In this episode, 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...
about 2 years ago • 3 min read