Clinical Trial Podcast | Conversations with Clinical Research Experts

In this interview with Dr. Jeffrey Kingsley, we talk about what it takes to start and manage a clinical trial site, the world of site networks, how an investigator can decide whether or not a clinical study is worth their time, volunteering for Association of Clinical Research Professionals (ACRP), Food and Drug Administration (FDA) audits, books and a lot more. Dr. Kingsley is the President and CEO; Institute for the Advancement of Clinical Trials DBA IACT Health and an owner of 11 clinical trial sites. He is a Fellow at Association of Clinical Research Professionals. Dr. Kingsley graduated with a master's in business administration from Emory University, a doctorate in osteopathic medicine from Philadelphia College of Osteopathic Medicine, a master's in science, biochemistry and a bachelor's of science, biology, chemistry, history, cultural anthropology from the University of Scranton. Please join me in this value-packed interview with Dr. Jeffrey Kingsley.

Ryan Jones, CEO and Co-founder of Florence Healthcare, shares his journey from tech to clinical trials, emphasizing the role of innovation in addressing major challenges. He discusses how e-regulatory solutions can streamline workflows and enhance site autonomy. The conversation shifts to the importance of building a strong team in clinical research and strategies for cold calling hiring managers to stand out. Ryan also touches on balancing personal life with professional innovation, providing valuable insights for aspiring entrepreneurs in healthcare.

"Technology makes our lives easier, but it doesn't replace people" - Melissa "Liss" Easy The dynamic, engaging Melissa "Liss" Easy is the Founder of clinical operations technology provider DrugDev, which is now part of IQVIA. Early in her career Liss was consulting to a Contract Research Organization and became frustrated by inefficiencies in matching investigators to pharma protocols. She started DrugDev to bring sponsors and investigators together by focusing on the needs of the doctors, giving them better technologies and service and more open communication.The DrugDev network Liss began now hosts over 85,000 active investigators in 120 countries in addition to profile and experience information for 450,000+ investigators from 85 pharma and biotech companies. And, DrugDev has expanded to offer a suite of clinical operations solutions used on nearly 2,000 clinical trials.Liss's honors include being named one of the PharmaVOICE 100 most influential people in life sciences; winning the Partnerships in Clinical Trials Woman of the Year award; and, being named to the a Philadelphia Business Journal Healthcare Innovator.Liss is an extraordinary example of how radical change is creating a new phase in clinical research. I hope you'll enjoy hearing this extraordinary woman's perspective on how technology can fundamentally change clinical trials and global healthcare for the better.About This Podcast EpisodeListen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." This episode is brought to you by CBI Events CBI has put together an Global Risk Based Monitoring event for clinical research professionals such as yourself. CBIs Global Risk-Based Monitoring event is back for its third year to bring together thought leaders from around the world to benchmark, share best practices, evaluate technologies, overcome operational hurdles and make the most out of RBM. Attend this year's event to gain best practices in protocol design, receive hands-on demonstrations of new technologies that you cannot learn in an RBM webinar, benchmark face-to-face with peers, develop new strategies in algorithm design and prepare for the future of RBM. Register today and get your $500 off your registration using the promo code CTP500. This is an exclusive offer is only available to the Clinical Trial Podcast listeners. Selected Links from the EpisodeDrugDev Society of Clinical Research Sites Why Isn't Your CRO Using E-Consent? Exl Events Investigator Database Bank connecting investigators with sponsors and CROs LastPass, an amazing password management tool SCRS Summit Books Lean In: Women, Work, and the Will to Lead by Sheryl Sandberg Show Notes: Making new pharmaceutical products available to patients who need them sooner [02:20] Making the leap from advertising and marketing [03:38] Disney to Drugs [05:10] Working on large deals at a CRO and pulling people together from different departments [06:23] Creating like a LinkedIn for investigators and sponsor companies [07:24] Moving away from contacting physicians via faxes to contacting them via email [08:26] Is there legal or regulatory reason as to why you can't do this in clinical research? [08:50] Reaching out to people your network, asking people what they want and questioning assumptions [10:19] Electronic patient consent [11:02] Fostering site and industry collaborations via the Investigator Database Bank [13:52] How to make sites lives easier? [15:09] Process for developing strategic partnerships with other organizations [16:22] Everyone wants experienced investigators, but if no one gives them that first chance [18:09] Advice for start-up founders [20:28] Choosing and attending conference [21:47] What are we doing in the 21st century that we must stop doing right now and get ready to change? [22:52] User experience, doing everything just once, and batching tasks [29:42] Once the site is activated, don't expect them to magically come up with patients [30:34] Ensuring you have a steady study pipeline as a clinical trial site [32:10] Is joining a site network worth it? [35:48] Getting started with new software technologies and importance of staff training [40:04] If you hire someone to do some work, you have to trust them [42:20] Hiring people [43:57] People underestimate how hard it is to manage people remotely [46:17] Building relationships, genuine relationships and being interested in people [47:43] You should listen to people, whether they be more senior or junior than you [49:46] Being a female, there are some additional challenges that you can have in the workplace [54:00] Subscribing to newsletters and attending conferences [55:22] Advice to her younger self [57:55] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

"I enjoy conversations. It takes you somewhere different" - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40 clinical studies and has been an integral part of the growth of GCP Research. Gabriel graduated from Concordia University with a BSc and a Specialization in Biology. He has also finished a follow-up Graduate Diploma program in Health Care Management from McGill University.Please join me in this fun and insightful conversation with Gabriel D'Amico-MazzaAbout This Podcast Episode Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode Connect with Gabriel D'Amico-Mazza on LinkedIn GCP Research Facebook Blueprint Health Canada Vantage Biotrials Clinical Research Association of Canada Association of Clinical Research Professionals Society of Clinical Research Associates Show Notes: Business development for clinical trials [01:06] Recruiting participants, why people want to be in clinical trials [02:36] The composition of a small site in clinical research [11:05] Process for building relationships with a network of doctors and specialists [13:20] Three things that motivate physicians [16:50] How doctors get paid in a hospital setting [20:04] Average bill rate for a general practitioner in Canada [21:16] Gabriel's journey from college to clinical research [24:02] Working with Quebec sites if you are a sponsor or CRO personnel from another country [28:00] Social media marketing to recruit trial patients [32:00] Key Performance Indicators (KPIs) at GCP Research [45:20] How to get feedback to improve clinical trial conduct [52:05] Attending clinical research conference [56:28] Email vs. calling people and why picking up the phone makes a difference [59:55] What was your favorite part of this interview? Let me know in the comments section below.

"We're at the threshold of an astounding period in medical discovery" - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data. Manuel and I had an amazing conversation about how we're missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues with clinical data sources. We also talked about life philosophy, clinical resources that can take your career to a different level and the pace of change in the life sciences industry. Hope you enjoy my interview with the all amazing Manuel Prado. About Manuel Prado Spending much of his youth in Lima, Peru, Manuel Prado attended Southern Methodist University before beginning his career in investment banking. When presented with an opportunity to take a year's sabbatical to travel the globe, he took it, meeting his now-wife in Thailand before returning to his California home. Inspired by his cultural journey, Prado soon founded the first of his three companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people globally.In 2010, Manuel Prado began to transition away from the daily management of VIVA and founded RealHealthData, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 100,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world. Prado is also the founder of Adhearx, a company that collects data from automated phone calls to patients, which reveal the true causes of medication non-adherence. About This Podcast Episode Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode Connect with Manuel Prado on LinkedIn The Center for Information and Study on Clinical Research Participation (CISCRP) The New England Journal of Medicine Kevin Kelly & The Inevitable Brene Brown 750 Words 5 Minute Journal Fierce Pharma Fierce CRO Fierce Biotech Fierce Medtech Center Watch Modern Medicine PM360 Pharmaceutical Executive Real Health Data Adhearx Show Notes: Manuel's journey into clinical research [01:48] Medical transcription and the problem RealHealthData is trying to solve [05:34] Analyzing claims and EMR data and how it's impacting recruitment in clinical trials [08:57] What physicians are looking at when making referrals to specialists [10:54]How clinical data companies can engage with sponsors [19:00] FDA and real-world data [27:52] Impact of real-world data on clinical roles [30:09] The pace of change in life science industry [35:52] Why you should consider journaling [43:17] Sabbatical and surfing [48:17] Passion and life philosophy [53:17] Where is reliable data coming from and what clinical researchers should focus on [55:29] Morning routine, staying focused and not getting distracted [59:17] Making mistakes and not failure [1:00:52] Two issues with data sources: Timeliness of data and data on female and minority participants [1:07:00] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

In this interview, Norm and I dig deep into the business of clinical research. You'll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more. Hope you enjoy my interview with the all amazing Norman Goldfarb. About Norman Goldfarb Norman Goldfarb is a seasoned executive and leading authority on clinical research best practices. He has authored or presented hundreds of articles and talks on clinical research. He is Managing Director of First Clinical Research, Editor of the Journal of Clinical Research Best Practices, and Chairman of MAGI. Show Notes: Norm's transition from high tech to clinical research via his work on a patient recruitment software [01:53] Why clinical research site business is a hard business [04:28] The career path of site principal investigators [06:20] Advice for recent graduates in the field of medicine [10:30] Challenges of being a study coordinator and how to overcome them [12:15] Pros and cons of remote monitoring [15:45] Importance of standardization in research [20:03] Model Clinical Trial Agreement Template [23:35] Resources of study coordinators negotiating clinical trial agreements [24:55] Ben Franklin [28:01] On writing controversial articles in clinical research [29:45] Certification in clinical research and does it matter [31:01] On negotiation [36:04] Two-year requirement for taking certification exams and what matters most in clinical research [40:25] High road marketing [49:31] Philosopher's Stone [53:29] Why should someone be in clinical research in the first place? [56:57]

"It is important that you start with the big picture" - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and Ph.D. from the Ludwig Maximilian University of Munich. In this interview, Manfred shares his personal story as a general physician for pilots to an industry professional in clinical trials. Manfred also has exceptional advice for physicians looking to get into clinical research. To wrap up, we talk about his role as a liaison between medical science and clinical operations. I hope you enjoy this interview with Dr. Manfred Stapff. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode: Connect with Manfred LinkedIn Lancet Drug Information Association (DIA) Association of Clinical Research Professionals (ACRP) Food and Drug Administration (FDA) Journal of Clinical Hypertension American Heart Association (AHA) New England Journal of Medicine (NJEM) TriNetX Merck Good Clinical Practice ICH Show Notes: About TriNetX [02:15] The changing landscape in protocol design [04:16] How TriNetX is helping scientist and health care organizations [06:57] What types of people are companies like TriNetX hiring [10:54] Transitioning from general physician for pilots to Merck [13:32] Advice for medical school students and graduates interested in clinical research [18:12] Working at CROs - what to expect [23:27] Why patient enrollment is challenging [25:29] Why should sites consider being part of networks such as TriNetX [28:11] How clinical (medical) and industry can be advantageous to you [31:08] Importance of doing the "dirty work" in clinical research [32:46] Importance of doing the "dirty work" in clinical research [32:46] Being open to other people's opinions [36:30] Dealing with tension between science and clinical operations [28:43] Keeping yourself informed about new clinical treatments and scientific findings [46:41] QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

"You have to forgive yourself and not expect perfection" - Robin Eckert In this episode, I had the privilege to talk to Robin Eckert. Robin is an engineer by training who later transitioned into clinical safety and clinical trial management. She is a very accomplished individual who has led complex structural heart medical device trials. Robin is also one of the most creative individuals in the clinical research space. If you're a gal (or a guy) wanting to transition into clinical research or change roles at your current company, Robin will inspire you with her personal story. We wrap up our discussion with top-notch resources in the interventional cardiology space. I hope you enjoy this interview with Robin as much as I did. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode Connect with Robin LinkedIn TVT Conference TCT MD FDA Resources Drugs Medical Devices Biologics Gray Sheet Cardiac Interventions Today Graphics Design: 99Designs Show Notes: Transitioning from R&D engineering to clinical research [02:39] Leading clinical safety and working independently [10:50] What it takes to switch roles [13:41] Finding mentors within clinical organization [16:08] Creativity in clinical research [19:01] Importance of marketing and messaging in clinical research [23:19] Tips and insights for CROs responsible for creating newsletters [29:18] How to get credibility among your peers, industry, understanding why something is important in the grand scheme of things [35:25] Attending conferences [37:27] QUESTION: What was most useful for you in this episode? Leave me a comment below and thanks for listening.

"Don't be afraid to try new things" - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you're interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode Connect with James LinkedIn Medicare International Society for Pharmacoeconomics and Outcomes Research (IPSOR) BIO conference Stanford Biodesign Program Centre for Health Economics at University of York The National Institute for Health and Care Excellence (NICE) What is a MAC? Hospital Readmissions Reduction Program Books Mentioned: Leading at Mach 2 by Steve Sullivan Good to Great by Jim Collins The Tipping Point: How Little Things Can Make a Big Difference by Malcolm Gladwell Biodesign: The Process of Innovating Medical Technologies by Paul G. Yock and Stefanos Zenios Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications) by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance Show Notes: What is Health Economics [01:52] James's personal story: career path to HEOR [06:09] Daily routine of HEOR professionals [13:26] NICE and other HTA [14:30] HTA in the United States [15:15] HTA vs. MAC [16:30] The future of HEOR [18:59] Hospital Readmissions Reduction Program (HRRP) [19:58] Economic value and what should a medical product start-up do? [24:17] How to find HEOR consultants [25:00] Qualities of HEOR people [28:06] Health economic model: how to make one? [28:57] Working with Medicare Administrative Contractor (MAC) [31:38] The future of HEOR (continued) [33:20] On Big Data [34:57] Leveraging HEOR data in countries such as US and Japan [36:52] How does HTA function in the US [38:26] Resources and guidance documents on HTAs [40:23] HTA review process in Japan [43:30] Trick to learning other therapeutic areas [47:55] What was most useful for you in this episode? Leave me a comment below and thanks for listening.

This is a solo episode where I share with you "13 Suggestions for Becoming a Great Clinical Project Manager." If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager. In this episode, I'll share with you the fundamentals, tactics and soft skills that turn a good project manager into a great project manager. At the most basic level, a project manager must be familiar with the clinical study protocol, clinical study procedure(s), and Good Clinical Practice (GCP) requirements. Next, a clinical project manager needs to be savvy with creating and managing study budgets, timelines and resources. Finally, the soft skills make a world of a difference between a good project manager and a great project manager. I'll share with you 6 specific soft skills that will help you exponentially if you are really serious about the clinical project manager role. Thanks to my blog reader Christopher B. for recommending this topic. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. About This Podcast Episode: Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode: Connect with me (Kunal) LinkedIn | Twitter The Ultimate Guide to Clinical Trial Costs FDA Good Clinical Practice Guidance Learn Microsoft Excel and other Microsoft Office Tools SkillShare Udemy YouTube Microsoft Office Products Microsoft Project to create timelines Microsoft Excel to create and manage study budgets and timelines Office Timeline, a Microsoft Powerpoint plugin that helps you create beautiful clinical trial timelines Create graphics and slides using Canva Books Mentioned: Sapiens: A Brief History of Humankind by Yuval Noah Harari The Inevitable: Understanding the 12 Technological Forces That Will Shape Our Future by Kevin Kelly Show Notes: Protocol, follow-up requirements and adverse event reporting [01:26] Understanding the clinical procedure [4:42] Good Clinical Practice [6:02] Managing a clinical study budget [7:20] Proficiency with Microsoft Excel [8:22] Developing and executing on study timelines [14:41] Managing study resources [22:05] Paying attention to compliance [24:02] Being self-aware [28:13] Being objective in your decision-making process [29:40] Being proactive and results driven [31:04] Ask questions and be curious [32:58] Explain your thought process [36:40] How to communicate effectively [38:05] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.