While the regulatory bodies have supported decentralization of clinical trials, prior to COVID-19 many sponsors were reluctant to adopt these tools in practice. The global pandemic has forced many to re-evaluate their stance on remote eClinical solutions. In this presentation, we will discuss the challenges and opportunities presented by these shifts and the impact on traditional eClinical technology companies as the industry moves more toward decentralized trials.
David Botts, Executive Vice President, Rose Research
David Botts is co-owner and Executive Vice President of Rose Research Center (RRC), a private research company located in Raleigh, North Carolina. RRC is a premier research company, leading the way in clinical trials to eliminate nicotine and smoking addiction. David is accountable for the overall success of operational activities at both company offices (Raleigh and Charlotte, NC). He is also responsible for establishing, overseeing and supporting all electronic research infrastructure and operational policies in parallel to industry regulations and standards for Information Technology. He is dually responsible for meeting all federally mandated compliance requirements for research on human subjects. In his spare time, David and his wife (and co-owner) Tanaia enjoy boating with friends and their three children. Additionally, they both enjoy various home projects usually accompanied with craft beer. David has a BA from North Carolina State University in Raleigh, North Carolina as well as a MS from University of North Carolina Wilmington in Clinical Research and Product Development.Message Presenter
Fred Martin, Chief Product Officer, Medrio
Fred Martin has built a career in healthcare over the course of nearly two decades, and has developed healthcare systems, BI/Analytics solutions, workflow tools for hospitals, and more. He has served in Director of VP positions at companies including PointClickCare, Press Ganey, and Premier Healthcare Alliance. He brings broad experience in user-centered design and bridging consumer-centric front-end web applications and technology infrastructures to his role at Medrio. Martin holds an MBA from the University of Michigan, Ann Arbor; an MILR from Cornell University; and a BA from the University of Colorado, Boulder.Message Presenter
Who Should Attend?
- Clinical Data Management Professionals
- Clinical Operations Professionals
- Clinical IT Professionals
- Clinical Innovation Professionals
- Clinical Research Professionals
- Medical Affairs Professionals
What You Will Learn
- Discover how the clinical trial landscape is shifting towards decentralization due to COVID-19 andlearn about innovation from the regulatory sector
- Learn how to integrate tools to help keep your studies in flight when patients can’t come to you
- Discuss the impact of mid-study protocol changes
Medrio is the leading provider of eClinical technology for early-phase pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, eSource, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit www.medrio.com.