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Plenary Session: The Future of Clinical Information Flow: Breaking the Document Paradigm
Session Chair(s)
Yatika Kohli, PhD, MBA
Chief Regulatory and Strategy Officer
NoNO Inc, Canada
Lorella Garofalo, PhD
Head of Regulatory Sciences
Pfizer Canada, Canada
This session will discuss how three different initiatives developed by a consortium of research and development organizations have come together to guide industry towards a future in which digital data flow moves seamlessly across the various systems and software used in clinical development. Clinical trial systems frequently have?bespoke data models and connections that typically require duplicate data entry, data transcription, and manual processes when transmitting data between or across systems, which often results in a lack of information flow across systems and process delays. The development of the Digital Data Flow (DDF) Initiative aims to catalyze industry-level transformation by enabling vendor-agnostic digital exchange of study definition information through the creation of a sustainable solution that incorporates innovative technologies and today’s industry standards. The session will also set DDF into context with other programs, as well as other industry and regulatory initiatives.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe how Clinical Content and Reuse (CC&R) and DDF initiatives propose to enable a shift toward increased reuse of study protocol information within studies and across the systems landscape
- Evaluate how industry initiatives are aligned with other efforts, such as ICH M11, to shift the industry toward less document-based information use and reporting
Speaker(s)
Speaker
Todd Georgieff, MBA, RPh
futurpositif - Digital Clinical Trials Consulting, Canada
Principal
Speaker
Nancy Tam, MS
Pfizer Inc, United States
Head of Medical Writing
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