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CFAST Initiative: Potential to Dramatically Increase ROI and Reduce Timelines in the Conduct of Clinical Trials
Session Chair(s)
Diane E. Wold, PhD
Director, Concept Modeling
CDISC, United States
The Coalition for Accelerating Standards and Therapies (CFAST) initiative has made progress in increasing the speed and number of therapeutic area (TA) standards developed. These accomplishments have the potential to dramatically increase return on investment and reduce the timeline in the conduct of clinical trials.
Learning Objective : Describe the CFAST initiative including the potential benefit of developing therapeutic area (TA) standards; Discuss the new regulatory environment including how standards are being increasingly adopted; Identify how TA standards can benefit your organization.
Speaker(s)
Recent FDA Guidance on Data Standards and CDISC Activities
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
CFAST: Innovative Approaches to Standards Development and ROI These Standards Can Facilitate
Diane E. Wold, PhD
CDISC, United States
Director, Concept Modeling
Maximizing The Value of Data Through Collaboration
Enrique Aviles
Critical Path Institute, United States
Chief Technology Officer
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