Tell the audience a little bit about yourself. I’m currently at TriNetX as the Senior Vice President of Clinical Science and Operations, but I’ve been in the clinical and life sciences industry for 22 years. Throughout my experience, I realized a big piece missing in using data to better clinical research was patient-level data. About five and a half years ago, TriNetX came to me and I realized this was a new company up to great things, including using data to advance clinical trial research and...
May 21, 2021•17 min•Ep 28•Transcript available on Metacast Tell us about your experience. After I finished medical school/neurology training, I started on faculty at Indiana University, School of Medicine in the neurology department. I ran a few clinical trials during my time there and became increasingly interested in clinical trial design. Beginning in 1998, I went to work at Eli Lilly and Co. where I focused on late phase work and worked primarily on Alzheimer’s. I started this consulting business about three years ago, and Cogstate was one of the fi...
Apr 16, 2021•21 min•Ep 27•Transcript available on Metacast To start off, why don’t you tell us about your experience in the clinical research field and a little bit about yourself. I have had 30 years of experience as an observer of the clinical research enterprise. First, my involvement in management consulting; then I started a publishing company called Center Watch which captured a lot of data and observations about the research enterprise and published that information. After I sold Center Watch, I moved into academia and the nonprofit world and I h...
Mar 16, 2021•20 min•Ep 26•Transcript available on Metacast Tell us a little bit about yourself and 1nHealth. I’m kind of a cross between a life science veteran and an e-commerce veteran. I created 1nHealth based on those philosophies to answer the question, “how do you use compelling marketing to incite individuals to take action?” At 1nHealth, we are putting an advertising catalyst in front of individuals in hopes of getting them to enroll in clinical trials. Early last year, the COVID-19 pandemic was beginning to impact sponsors' ability to run clinic...
Feb 16, 2021•14 min•Ep 25•Transcript available on Metacast Jim, tell us a little bit about yourself and your work at ACRP. I started my career at Eli Lilly for 24 years before moving to Quintiles, now known as IQVIA, for 5 years. After spending the following five years consulting, I became the executive director for ACRP. ACRP recently released some data on the state of the clinical trial workforce. I want to dive into what that data revealed. What trends are you seeing in clinical research career opportunities right now? Recent trends in clinical resea...
Dec 14, 2020•17 min•Ep 24•Transcript available on Metacast Fabian, tell us a little bit about yourself and your experience. I’m Colombian, but I was raised in northern Virginia. I got a bilingual medical training and moved on to research after my residency. I soon realized I wasn’t keen on the monotony of regular medical practice. I ended up moving into clinical trials and research and have been in the industry ever since. You’re a key member of the SCRS’s Diversity Awareness Program. Can you tell us about your history with the program? SCRS started thi...
Nov 17, 2020•23 min•Ep 24•Transcript available on Metacast Fabian, tell us a little bit about yourself and your experience. I’m Colombian, but I was raised in northern Virginia. I got a bilingual medical training and moved on to research after my residency. I soon realized I wasn’t keen on the monotony of regular medical practice. I ended up moving into clinical trials and research and have been in the industry ever since. You’re a key member of the SCRS’s Diversity Awareness Program. Can you tell us about your history with the program? SCRS started thi...
Oct 26, 2020•9 min•Transcript available on Metacast Host Jason Eger is joined by Dr. Diana Foster, Vice President of Strategy and Special Projects at the Society for Clinical Research Sites, to discuss how clinical research sites can help the industry improve patient diversity in clinical research.
Sep 30, 2020•21 min•Ep 23•Transcript available on Metacast Tell us about TrialScope and your experience. I am the Vice President of Patient Engagement at TrialScope. I used to work at the Michael J. Fox Foundation for Parkinson’s Research and also had my own company, Clinical Trial Connect, before it was acquired by TrialScope last year. I’ve been working in the clinical trial recruitment world for the past ten years. I am overseeing a new product called TrialScope Connect, which sets sponsors up for success when it comes to clinical trial improvements....
Aug 25, 2020•19 min•Ep 22•Transcript available on Metacast Speaking from a general safety perspective, as well as a cardiac safety perspective, what challenges have you observed in clinical trials resulting from the COVID-19 pandemic? [3:07] I speak for myself and others, no one trained us for this and we had to quickly react. We want to ensure the safety of the participant as well as making sure the data is right. We have to consider what is in the best interest of the patient and how we can ensure that the data that is collected will be able to be ana...
Jul 14, 2020•22 min•Ep 21•Transcript available on Metacast How did you end up in patient advocacy? At the time of her first diagnosis, Deb was a computer company executive. Along with her husband (also a cancer survivor), she got involved with an oncology patient advocacy group. This was in the early 1990s when very little was known about effective cancer treatments, and she felt that this was important to change Can you explain the role of a patient advocate? A patient advocate contributes in a dramatic way to improve the experience of patients they do...
Jun 16, 2020•22 min•Ep 20•Transcript available on Metacast Introduction [00:55] Dr. David Albert of AliveCor explains how patient-collected data can solve some of the problems facing clinical trials during the COVID-19 pandemic, as well as the long-term outlook on changes in data collection for clinical research. What is the AliveCor KardiaMobile 6L and how does it work? [01:43] The AliveCor KardiaMobile 6L is a 6-lead device for patient-collected ECG/EKG reads. How is the KardiaMobile 6L being used today in light of the COVID-19 pandemic and subsequent...
May 05, 2020•19 min•Ep 19•Transcript available on Metacast Introduction [00:55] Nadeeka Dias and Chris Watson from ERT discuss the race for a coronavirus vaccine and take a deeper dive into how sponsors and CROs can use technology to address the unique challenges of vaccine trials. What are the specific challenges sponsors face in trying to create a COVID-19 vaccine? [02:10] The real challenge is that the threat is now, so time is not on our side. However, good clinical research takes time. Because there are currently no approved vaccines or treatments ...
Apr 14, 2020•18 min•Ep 18•Transcript available on Metacast Introduction We welcome Nicholas Conn from Heart Health Intelligence and Jean-Phillippe Couderc from VPG Medical as he joins Trial Better to discuss passive health monitoring and the smart toilet seat. What is the Heart Seat and what does it do? The Heart Seat is a cardiovascular monitoring system integrated into a toilet seat. This allows you to monitor a comprehensive set of measurements in the home without requiring patients to change their behavior at all. The Heart Seat automatically starts...
Mar 17, 2020•18 min•Ep 17•Transcript available on Metacast Intro Dawn Patterson, ERT Director of Respiratory Solutions, is joined by Kevin McCarthy, ERT Clinical Overread Specialist and member of the ATS/ERS 2019 Spirometry Update Task Force. They’ll explore the implications of the October 2019 ATS/ERS update to their pulmonary function testing guidance. ERT was the only data and technology vendor involved in the update. What are the ATS/ERS guidelines? These guidelines represent what can be considered as worldwide standards that ensure the quality of p...
Feb 11, 2020•16 min•Ep 16•Transcript available on Metacast What trends have you seen in respiratory in 2019? In previous years, there were a number of blockbuster drugs developed for conditions like asthma and COPD. However, these drugs are beginning to move off-patent, so the industry is beginning to see studies for generics taking place. Because these blockbuster drugs are still on the market, sponsors are instead looking for new indications to apply these treatments to, where they might achieve small benefits. In order to find these incremental effec...
Dec 19, 2019•12 min•Ep 15•Transcript available on Metacast What trends have you seen in imaging in 2019? One of the biggest trends has been an increase in demand for imaging over the last year as more and more trials have begun to require imaging as a primary endpoint. This has always been common in oncology studies in particular, but not the industry is starting to use imaging as a primary endpoint in other indications as well. What do you think the future looks like? In 2020 and beyond, there will be a push toward siteless trials. In imaging, we may b...
Dec 18, 2019•6 min•Ep 14•Transcript available on Metacast What trends have you seen in eCOA in 2019? There’s been a shift in the regulatory landscape over the past year, shaped by an ongoing effort since the launch of 21st Century Cures Act to update patient-centered outcomes. The FDA has also taken on the task of updating guidance to industry published in 2009 on the use of PROs, culminating in the drafting of a fourth new guidance. In early 2020, we can expect to see a new draft guidance reflecting not only updates to technology over the last 10 year...
Dec 17, 2019•8 min•Ep 13•Transcript available on Metacast What have you seen and experienced in cardiac safety in 2019? Cardiac safety is typically seen as a very stable area. However, in 2019, there was a lot of evolution as sponsors began to look for ways to reduce patient burden and find real-world cardiac evidence . Enter wearables: advancements in these convenient devices have made it possible to track patients’ health and the safety and efficacy of therapies at home, as in Stanford Medicine’s Apple Heart Study. This trend also reflects the shift ...
Dec 16, 2019•8 min•Ep 12•Transcript available on Metacast Introduction [00:50] We welcome Jean-Phillippe Couderc from VPG Medical as he joins Trial Better to discuss passive health monitoring and VPG Medical ’s technology, HealthKam. What is passive health monitoring? [02:02] Passive health monitoring, or opportunistic monitoring, embeds sensors that measure data into technologies or devices that are already used by the patient in everyday life, like smartphones, bath mats, and toilet seats. These devices place minimal constraints on the patient wherea...
Dec 03, 2019•20 min•Ep 11•Transcript available on Metacast What is a micropayment? [02:16] Micropayments are a small financial transaction. The threshold for what is considered a micropayment can vary based on industry, geographic location, and other factors. In clinical research, micropayments can influence and encourage patients to take complete any actions outside of a clinical visit that may be necessary. Why are micropayments a hot topic right now? [02:58] The clinical research space has reached an inflection point. Previously, there was resistance...
Nov 19, 2019•16 min•Ep 10•Transcript available on Metacast Introduction [00:42] Learn about best practices for patient recruitment, one of the biggest concerns in the clinical trial industry. We’ll discuss the importance of precision recruitment and site-follow up, as well as patient recruitment challenges like diagnosis, eligibility and diversity. What’s the number one problem with clinical trials? [03:03] The number one problem with clinical trials is speed. Research isn’t happening as quickly as it should, and patients are waiting too long for new an...
Oct 29, 2019•23 min•Ep 9•Transcript available on Metacast Introduction [00:20] Phil Lake and Dr. Kai Michael-Beeh examine the steps sponsors and study teams can take to improve data quality and reduce data variability in respiratory trials. They also discuss the innovations and trends they expect to see in the industry in the future. How can sponsors and the pharma industry overcome unacceptable data variability from sites? [03:30] Respiratory measurements can be complicated and challenging if study teams don’t stick to the fundamentals. This means tha...
Oct 15, 2019•26 min•Ep 8•Transcript available on Metacast Introduction [00:45] Ken Faulkner and Katarina Krosback explore the potential benefits and pitfalls of Bring Your Own Device (BYOD) in eCOA clinical trials, as well as the current regulatory perspective. In this episode we discuss the future hold of BYOD, the value of patients using their own devices and the technology needed for BYOD trials. What does “BYOD” mean in the context of a clinical trial? [03:33] In BYOD, or bring your own device, the patient uses their own cell phone to complete thei...
Sep 23, 2019•16 min•Ep 7•Transcript available on Metacast Patricia Castellano and Emily Olsson explore how sites can benefit from developing a stronger relationship with their ABPM device vendors. They also address strategies for successful repeat ABPM sessions when a patient is non-compliant, and how ABPM achieves a type of holistic data not possible with other BP measurement methods. Introduction [00:37] Patricia Castellano, Senior Director of Product Management at ERT, is joined by Emily Olsson, CCRP, from the University of North Carolina Chapel Hil...
Sep 10, 2019•17 min•Ep 6•Transcript available on Metacast Introduction [00:31] Patricia Castellano, Senior Director of Product Management at ERT, is joined by Emily Olsson, CCRP, from the University of North Carolina Chapel Hill for an in-depth look at the keys to implementing a successful ABPM protocol in a cardiac safety tril. Enhancing Data Quality and Value with Hands-On Training [2:31] Hands-on training provides benefits to both patients and site staff. Participants who receive training feel more engaged in the ABPM data collection process and are...
Aug 19, 2019•13 min•Ep 5•Transcript available on Metacast Drew Bustos, Senior Director of Business Intelligence Products, is joined by Dr. Santikary, Vice President and Global Chief Data Officer at ERT, for a discussion of the role of modern data architecture. Clinical trial sponsors and CROs are facing increasing numbers of complex data integration and quality challenges. Are you struggling to keep up with this exponential data growth? The solution may lie in modern data platform, cloud, and artificial intelligence technologies. Data Architecture Chal...
Jul 29, 2019•14 min•Ep 4•Transcript available on Metacast Introduction Vivienne de Walle, Co-Founder of PT&R - a dedicated clinical trial site in the Netherlands, is joined by Chris Porter, VP of Marketing & Digital Strategy, ERT for a discussion about the importance of involving clinical sites in the design of clinical studies. Sites are on the frontline of your clinical trials and as such, bring with them a wealth of experience and advice on how to make trials run more smoothly and efficiently, ultimately bringing drugs to market faster. Here...
Jun 21, 2019•39 min•Ep 2•Transcript available on Metacast Introduction Brett Hoover, Product Management team lead for ERT’s imaging product line, is joined by Amit Vasanji, Chief Technology Officer of imaging at ERT, for a look at imaging trends, strategies, and best practices in the clinical trial industry. How can using imaging effectively reduce cost? What impact will innovative imaging approaches have on a trial? What do sponsors need to know in order to maximize the benefits of imaging? The Growth of Imaging in Clinical Trials Over the last ten ye...
Jun 21, 2019•28 min•Ep 3•Transcript available on Metacast note
Jun 20, 2019•36 sec•Ep 1•Transcript available on Metacast 
