As technology in the modern world continues to advance at an increasingly rapid pace, the clinical research industry has been more conservative in the adoption of new tools and innovations. However, mass adoption of technologies in favor of the transformative value proposition that such advances provide ultimately occurs. One such example in clinical research is with electronic data capture (EDC). First developed in the late 1980s, it took 20 years for EDC to truly take hold and become the standard approach to collecting patient CRF data. Since then, it has continued to evolve through methods like electronic patient-reported outcomes (ePROs) and has delivered tremendous value to research organizations by enabling a more accelerated review of higher-quality data, with significant resource efficiencies gained as well.

Another newer example of an innovation that stands to revolutionize clinical trial processes is digital health technologies. These technologies, including wearable fitness devices, in-home clinical-grade devices, sensors and health applications, collect meaningful patient-generated health data (PGHD) directly from trial participants at home and as they go about their daily activities. Today, sponsors are beginning to utilize digital health technologies to enable sponsors to streamline subject recruitment, remote patient monitoring, medication adherence and post-marketing research. However, given the transformative potential that these devices provide for clinical research and the robust infrastructure and services already in place to enable effective collection and management of PGHD, broader adoption of digital health technologies is occurring quickly.

In this webinar, Jennifer Plumer from Validic and Ken Light from OmniComm will discuss in greater detail the digital health market and the tremendous positive impact it can have for clinical research right now and in the coming years. We will also explore EDC’s vital role as the industry continues to move away from a traditional “manual data transcription” paradigm into the emerging “electronic direct source capture” paradigm, and help you assess to what extent your EDC provider is positioned to address the new landscape.

Speakers

Ken Light, EVP of Transformation and Professional Services, OmniComm Systems

Ken Light is EVP of Transformation and Professional Services at OmniComm Systems, where he oversees projects to support technology transfer, integration, training, migration and business process improvement for the global Life Sciences community. Ken is also a subject matter expert and frequent presenter at industry conferences related to clinical trial technologies and process optimization.

Prior to joining OmniComm Systems, Ken oversaw similar clinical strategy and technology consulting practices for Oracle Corporation, BusinessEdge Solutions, and First Consulting Group. For the past twenty years, Ken has delivered technology and business strategy services to the majority of top twenty Pharmaceutical manufacturers, along with many smaller health and life sciences organizations.

Mr. Light has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.

Jennifer Plumer, Pharma/CRO Lead, Validic

As the Pharma/CRO Lead at Validic, Jennifer is focused on educating sponsors and CROs on the value of wearables, in-home clinical devices and mobile apps and advising them on how to transform market strategies and clinical trials with digital health. Jennifer brings more than 10 years of strategic marketing experience in the life sciences technology industry. She received her MBA from Liberty University and BA from the University of North Carolina at Chapel Hill.

Who Should Attend?

  • Heads of Clinical Data Management
  • Heads of Clinical Innovation
  • Heads of Clinical IT
  • Heads of Clinical Operations
  • Heads of Clinical Research
  • Heads of Clinical Systems
  • Heads of Medical Affairs

Xtalks Partners

OmniComm

Bioclinica’s Post-Approval Research division, a niche specialty clinical service provider, is dedicated exclusively to post-approval research. Our focus is in designing and conducting post-approval research for observational studies, post-marketing commitments, and large, simple trials. We also provide unparalleled expertise in post-approval safety studies. We offer comprehensive, innovative, technology-driven, cost-effective solutions with full-service capabilities for Pharmaceutical, biotech, and medical device companies.

Validic

Validic provides the industry’s leading digital health platform connecting pharmaceutical companies, providers, payers, wellness companies and healthcare IT vendors to health data gathered from hundreds of in-home clinical devices, wearables and consumer healthcare applications. Reaching more than 223 million lives in 47 countries, its scalable, cloud-based solution offers one connection to a continuouslyexpanding ecosystem of consumer and clinical health data, delivering the standardized and actionable insight needed to drive better outcomes and streamline clinical trial processes including remote patient monitoring, recruitment and pre-clinical and post-marketing research. Validic was named to Gartner’s “Cool Vendors” list and received Frost & Sullivan’s “Best Practices and Best Value in Healthcare Information Interoperability” and “Top 10 Healthcare Disruptor” awards. To learn more about Validic, follow Validic on Twitter at @validic or visit validic.com.

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