48 episodes

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 clinicaltrialpodcast.com.

Clinical Trial Podcast | Conversations with Clinical Research Experts Kunal Sampat | Educator

    • Business
    • 4.7 • 37 Ratings

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 clinicaltrialpodcast.com.

    Medical Imaging in Clinical Trials with Elizabeth Dalton

    Medical Imaging in Clinical Trials with Elizabeth Dalton

    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, and more.
    The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.  
    Liz is a seasoned clinical trial professional with 17+ years of experience working with sponsors, sites, and CROs in centralized medical imaging and clinical trials.
    Driven by a passion for service, Liz’s ethos is rooted in honesty, productivity, commitment, and the power of positive energy. 
    In addition to her primary role of growing the Calyx partnership/CRO channel, Liz leads a team of technical solution consultants and is a medical imaging consultant herself. 
    Liz attended the University of Massachusetts where she achieved dual Bachelor degrees in Anthropology and Economics (magna cum laude) and will graduate in May 2023 with her MBA from Boston University’s Questrom School of Business. 
    Please join me in welcoming Liz on the Clinical Trial Podcast. 
    This episode is brought to you by Calyx. To learn more about Calyx, please visit https://www.calyx.ai/ 

    • 1 hr 9 min
    Clinical Research Data Transparency with Darshan Kulkarni

    Clinical Research Data Transparency with Darshan Kulkarni

    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, I invited Darshan Kulkarni to the show.
    Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker.
    He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice.
    He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.
    He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry. 
    Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise.
    Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry.
    This podcast is brought to you by Florence Healthcare. The learn more, please visit florencehc.com
     

    • 43 min
    Launching an NIH Funded Study with Dr. Manish Shah

    Launching an NIH Funded Study with Dr. Manish Shah

    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 invited Dr. Manish Shah,  Professor of Pediatrics at Baylor College of Medicine and Attending Physician in the Texas Children’s Hospital Emergency Center in Houston. 
    Dr. Shah has served on several national committees to advocate for improvements in pediatric and prehospital emergency care. 
    His research has focused on developing, implementing, and studying outcomes related to evidence-based protocols for various clinical conditions, including seizures. 
    Dr. Shah is currently the Principal Investigator for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study, which has been funded by the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted in the Pediatric Emergency Care Applied Research Network (PECARN).
    Please join me in welcoming Dr. Shah on the Clinical Trial Podcast. 
    This episode is brought you by Florence Healthcare. To learn more, please visit https://florencehc.com/

    • 56 min
    Introduction to Coverage Analysis with Kelly Willenberg

    Introduction to Coverage Analysis with Kelly Willenberg

    • 54 min
    Clinical Data Management with Mariam Mirgoli

    Clinical Data Management with Mariam Mirgoli

    • 55 min
    Clinical Research Billing for Small to Medium Sites with Kristi Etchberger

    Clinical Research Billing for Small to Medium Sites with Kristi Etchberger

    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 cash and accrual based accounting, and more,  I invited our guest, Kristi Etchberger, on the show.   Kristi founded Clinical Research Billing in 2015 to help independent research sites manage their CTMS and generate cash flow through invoicing and collections. After nearly seven years, she and her partners have built Clinical Research Billing into a successful, growing small business. Kristi served as Chief Executive Officer of Atlantic Clinical Research Collaborative in Palm Beach County, Florida, where she oversaw the implementation of a clinical trial management system. 
    Kristi is an experienced corporate executive with a background in corporate finance and international equity markets. 
    Kristi received her M.B.A. in finance from The Wharton School at the University of Pennsylvania, B.A. in economics and psychology from Pitzer College, Claremont, California, and the Chartered Financial Analyst designation from the CFA Institute. 
    She studied pharmaceutical law at Seton Hall University.
    Please join me in welcoming Kristi on the show.
    This poodast is brought to you by Florence Healthcare. To learn more, please visit https://florencehc.com/.
     

    • 59 min

Customer Reviews

4.7 out of 5
37 Ratings

37 Ratings

KTPower35 ,

Wonderful Podcast

A wonderful podcast that flows really well! Kunal asks some great questions that listeners want to know. A nice variety of topics and very enjoyable overall! Even to someone new in the clinical trial world!

Pastafaz ,

Very professional and well formatted

This show is packed with efficient and relevant info. No wasting of anyone’s time.

Kmhcarr ,

Love Kunal

As a pharmacist looking to get into the clinical research industry, I have found The Clinical Trial Podcast indispensable. Kunal's articles about gaining experience are especially helpful. I have put his advice into action, and am making progress! If you are looking to get into or improve yourself in this industry, listen to this podcast!!

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