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Wednesday, June 26 • 2:00pm - 3:15pm
#357: Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-696-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Stacy Tegan


Vivian Combs, MS

Kelly Lengyel, MS

Yihua Gu, MS


Vivian Combs

Advisor/Process Owner, Clinical Systems and Supply Planning, Eli Lilly and Company
Vivian Combs currently leads the TransCelerate workstream responsible for the development of the TransCelerate Clinical Template Suite. She is the rapporteur for the ICH M11 CESHarP (Clinical Electronic Structured Harmonized Protocol) Expert Working Group, and is a full-time Process... Read More →
avatar for Yihua Gu

Yihua Gu

Director of Statistics, Abbvie
Yihua has dedicated 22 years of career in Abbott/Abbvie. Her experience spans across immunology, neurology, infectious diseases, and analgesia. Her combined statistical knowledge, scientific insights, the ability to look beyond statistics and the operation excellence have made her... Read More →
avatar for Kelly Lengyel

Kelly Lengyel

Director of Medical Writing, Allergan
Kelly Lengyel is a Director of Medical Writing at Allergan and oversees the medical writing team for multiple therapeutic areas. Kelly has nearly 15 years of regulatory affairs and medical writing experience across multiple pharmaceutical companies. Over the course of her career in... Read More →
avatar for Stacy Tegan

Stacy Tegan

Senior Program Manager, Transcelerate Biopharma Inc.
Stacy Tegan is a Sr. Program Manager at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session
  • Level Intermediate
  • Featured Topics Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session