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Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite
Session Chair(s)
Stacy Tegan
Program Director, Transcelerate Biopharma Inc., United States
This session will include presentations to introduce the new Common SAP and CSR templates, describing how these were designed and the key guiding principles in their structure, content, and format. Attendees will hear learnings from early case studies.
Learning Objective : Describe the Clinical Template Suite (CPT-SAP-CSR) developed by an industry member consortium; Analyze the new Common Statistical Analysis Plan and Clinical Study Report templates; Explain how this technology enabled edition allows for content use across the protocol, statistical analysis plan and clinical study report.
Speaker(s)
Vivian Combs, MS
Executive Director, Clinical Trial Foundations, Eli Lilly and Company, United States
Panelist
Kelly Lengyel, MS
Director, Global Medical Writing, Regulatory Affairs , Daiichi Sankyo, United States
Panelist
Yihua Gu, MS
Vice President, Head of Statistical Sciences, AbbVie, United States
Panelist
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