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Protocol Developments of the Future
Session Chair(s)
Bob Brindle, MA
VP Product Management
Nurocor, United Kingdom
This forum will discuss specific areas in the protocol development process and the use of emerging technologies.
Learning Objective : Identify where and how technology can be applied to improve or transform traditional protocol development processes: Describe best practices for creating, managing and implementing templates, and standard re-usable content; Discuss how consistently drafted protocols can lead to better success in a regulatory submission and aligned global transparency: Explain how to succeed developing protocols and managing amendments for complex study designs including master protocols.
Speaker(s)
Enforcing Better Standards in Protocol Development
Bob Brindle, MA
Nurocor, United Kingdom
VP Product Management
Objectives, Endpoints, and Outcome Measures: Developing Protocols to Achieve Consistency Between Documents and Registrations
Nate Root, MSC
Ionis Pharmaceuticals, United States
Associate Director, Disclosure and Transparency
Using Technology Innovations to Navigate Substantial Protocol Amendments for Studies with Complex Innovative Design
Rachael Cui Song, MBA
PPD, United States
Associate Director, Global Project Management
Protocol Development of the Future
Robert DiCicco, PHARMD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management