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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)
Panelist
Vivian Combs, MS
Eli Lilly and Company, United States
Director of Scientific Communications
Panelist
Kelly Lengyel, MS
Allergan, United States
Director, Global Medical Writing, Regulatory Affairs
Panelist
Yihua Gu, MS
Abbvie, United States
Senior Director of Statistics, Immunology TA Head
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