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Protocol Trends and Strategies for Quality
Session Chair(s)
Linda Fossati Wood
President
MedWrite, Inc., United States
Assessing the Impact of Regulatory and Scientific Pressures on Protocol Design
Learning Objective : Discuss the value of protocol review committees to improving protocol quality; Describe protocol design elements associated with specific objectives and endpoints; Recognize how a medical writer’s perspective can improve data collection and analysis tools; Identify key points to look for when reviewing case report forms and statistical analysis plans; Name suggestions for improvement of these documents.
Speaker(s)
Protocol Quality Tools: New Approaches to an Old Problem
Anne Cropp, PharmD
Early Access Care LLC, United States
Chief Scientific Officer
Assessing the Impact of Regulatory and Scientific Pressures on Protocol Design
Kenneth Getz, MBA
Center For the Study of Drug Development, United States
Tufts Center for the Study of Drug Development
After the Protocol: How Medical Writer Engagement During the Lifespan of a Study Can Help Ensure Quality Results
Kim Jochman, PhD
Merck & Co., Inc., United States
Senior Director, Medical Writing
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