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Thursday, June 18 • 5:00pm - 6:00pm
#506 OD: ON DEMAND - The Power of Real World Data and the Innovative Approaches for Usage

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Component Type: Session
Level: Intermediate

Real world data (RWD) comes from a variety of secondary technology sources, including electronic medical records, payer and consumer data, wearable technology, electronic assessments, and patient portals, covering a very heterogeneous range of data sources to be contemplated when developing clinical data sets to meet regulatory needs. Collecting and converting this data into models for analysis is complex. This session will describe our initiative to test the requirements to create clinical data sets from a representative yet full range of RWD sources, and traditional EDC data, to move toward implementation of new RWD technologies to benefit clinical research. A trial was designed and conducted using data from a variety of sources including electronic medical records, patient reported outcomes, wearables, labs and EDC data. Dataset development and derivation was tested completely through tables, listings and figures creation and analysis. In keeping with the proof-of-concept objective, the analyses were not intended to demonstrate statistically or clinically relevant results, but instead to ensure that analyses could be successfully performed on the clinical data set. Attendees will understand how real-world data can be leveraged, integrated and analyzed in the context of the clinical research needs of the life sciences industry.

Learning Objectives

Translate real world data (RWD) needs into meaningful clinical research designs; Describe how to to use tokens in RWD-enabled clinical research to protect patient privacy; Describe how existing processes used to meet Good Clinical Practice (GCP) requirements must be evaluated and adapted to go beyond what is used today for Electronic Data Capture (EDC).


Keith Wenzel


Results from a Proof-of-Concept Study to Demonstrate the Integration of Five Real-World Data Sources with EDC
Keith Wenzel

Real World Data Combined With Powerful New Technologies is Disrupting How Clinical Research is Done
Jeff Elton, PhD, MBA

avatar for Keith Wenzel

Keith Wenzel

Volunteer, DIA Study Endpoints Community, United States
Mr. Wenzel worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with... Read More →
avatar for Jeff Elton

Jeff Elton

Chief Executive Officer, Concerto HealthAI
Jeff Elton is CEO of Concerto HealthAI, a leader in real world data and AI solutions that tackle healthcare’s most pressing challenges, from reducing clinical development timelines to improving patient outcomes in oncology. Previously, Jeff served as Managing Director in Accenture... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session