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Tuesday, June 26 • 10:30am - 11:45am
#227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

TransCelerate BioPharma common protocol template (CPT) was first released in December 2015. It was updated in 2017 based on collaboration with NIH-FDA to align templates from both organizations. Since the initial release CPT has been downloaded over 3,700 times by several hundred unique clinical research organizations including Pharma, CROs, academic institutions and health authorities. In 2016 the project initiated proof of concept programs, using the technology enhanced CPT, with the aim of demonstrating automated reuse of protocol information for critical activities such as eCRF generation and registry posting. The session will focus on the development of prototypes which deliver high value applications of a machine readable protocol. In addition, a model which describes traceability from protocol to report will be described. Current applications of the technology enabled edition of the CPT will also be presented.

Learning Objectives

Discuss the benefits of digital data flow, including accelerating time to study start up; Describe how the technology enabled edition of the CPT delivers automated traceability; Discuss future opportunities for implementation.

Chair

Robert A. DiCicco, PharmD

Speaker

Panelist
Richard (Reb) Buckley, JD, MBA

Panelist
Jeff Beeler

Panelist
Michel Rider, DrMed



Speakers
avatar for Jeff Beeler

Jeff Beeler

Client Executive, Watson Health, IBM Watson Health
RR

Richard (Reb) Buckley

Clinical Innovation, TransCelerate Program Lead, Operations Center of Excellence, Pfizer Inc
Reb works in the Clinical Innovation group for Pfizer. In his position he focuses on leading initiatives that will transform the conduct of clinical trials in the industry. Since 2012, Reb has worked as the Program Lead at Pfizer for the TransCelerate initiatives. Through his Program... Read More →
avatar for Robert DiCicco

Robert DiCicco

Executive Consultant, TransCelerate Biopharma Inc.
Rob DiCicco is an executive consultant for TransCelerate. He is the Executive Sponsor for the Common Protocol Template Project and was one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His... Read More →
MR

Michel Rider

Managing Director, Life Sciences Cloud Strategy, Accenture


Tuesday June 26, 2018 10:30am - 11:45am
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA