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The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols
Session Chair(s)
Anne Cropp, PharmD
Chief Scientific Officer
Early Access Care LLC, United States
Benchmarking the Clinical Budget and Outsourcing Processes
Learning Objective : Discuss the impact of regulatory-mandated protocol amendments have to organizations; List the considerations that can be used for internal planning or CRO partner guidance; Describe the communication needed to various stakeholders.
Speaker(s)
Lessons Learned from Recent Implementation of Legislation-Required Safety Language into Protocols: Cost, People, Planning
Anne Cropp, PharmD
Early Access Care LLC, United States
Chief Scientific Officer
Use of Virtual Population Simulation to Improve Protocol Design and Amendment Management
Badri Rengarajan, MD
Jazz Pharmaceuticals, United States
Life Sciences
Benchmarking the Clinical Budget and Outsourcing Processes
Stella Stergiopoulos, MPH, MS
EQRx, United States
Director, Health Economic and Outcomes Research
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