On October 24th, 2017, Collaborations in Clinical Research hosted an insightful panel discussion on the topic Practical Uses of Electronic Health Records in Clinical Trials.
As a sponsor, it is important to understand how to use the various types of electronic health records in support of a clinical trial. For example, physician narratives can allow an orphan disease company to focus on symptoms when trying to identify patients. ICD 10 codes are an effective to identify known diagnosis. The skillful use of electronic health records can facilitate:
- Ensuring patient populations match your protocol inclusion/exclusion criteria;
- Identifying sites with potential trial subjects;
- Collection of clinical trial data.
An event sponsored by
Dr. Manfred Stapff | Chief Medical Officer, TriNetX
Dr. Manfred Stapff is Chief Medical Officer of TriNetX, the Global Health Research Network for Healthcare Organizations, BioPharma & CROs. He oversees all medical and scientific aspects of the TriNetX Network, such as epidemiologic analytics, protocol review and feasibility, query design, site identification/evaluation, and other aspects of Clinical Operations. Manfred has more than 20 years of experience in clinical drug development. Before joining TriNetX, he worked at Forest Laboratories, Inc. (now Allergan plc) and at Merck & Co, Inc. with increasing responsibilities in Clinical Development, Medical Services, Global Clinical Operations, Quality Management, and Training. Manfred started his medical career as a physician in the Institute of Air and Space Medicine of the German Airforce and in the University of Munich, Policlinic for Internal Medicine.
He received his MD and PhD from the Ludwig Maximilian University of Munich, Germany, and a Clinical Pharmacology license from the Bavarian Physicians Chamber. His publication list includes abstracts, papers, and books in cardiovascular medicine, drug development, project management and the use of electronic medical records in clinical development.
Hugh P. Levaux, PhD | Founder and CEO, Protocol First
Dr. Hugh Levaux is Founder and CEO of Protocol First. The company offers an innovative EDC Platform for Next-Generation Clinical Trials. Dr. Levaux brings to Protocol First 18 years of dedicated experience in clinical trial design and operations, as well as web-based technologies—notably, Senior Vice President at United BioSource Corporation (UBC), Vice President of Product Strategy at Medidata Solutions; CEO of Ninaza, a web-based EDC provider; and Senior Vice President at Quintiles Transnational. Dr. Levaux has developed and commercialized multiple eClinical technologies in EDC, IVR/RTSM, ePRO/eCOA and trial-related technologies.
Prior to his career in the clinical trials industry, he worked as an analyst at the RAND Corporation, where he worked for US government clients (US Air Force and intelligence community) and private sector clients (oil and aerospace). Before RAND, he worked in Japan at Panasonic. He is fluent in English, French, Spanish and Japanese. Dr. Levaux holds a Ph.D. in Policy Analysis from the RAND Graduate School and has also received master’s degrees in international economics and international relations from SAIS at Johns Hopkins University and international politics from Université Libre de Bruxelles in Belgium.
Manuel Prado | Founder , RealHealthData and Adhearx
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.
Moderated by Kunal Sampat | Senior Manager Clinical Programs, Abbott Vascular
Kunal Sampat is a Senior Manager Clinical Research at Abbott Vascular and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning.