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Session 9 Track 2: Transforming Clinical Trial Protocol Development: A Modern Approach
Session Chair(s)
Elizabeth Olbrich, MS, RN
Associate Director
Evidera | PPD, United States
This session will dive into topics that present challenges and opportunities in clinical trial protocol development. Speakers will present, how decentralized trials affect approaches to writing effective protocols, and how patient input can help engage patients and enhance protocol design and the role of generative AI and it’s potential in revolutionizing protocol creation.
Learning Objective : - Discuss decentralized clinical trial methodologies during the protocol planning process and identify protocol sections impacted by the addition of decentralized clinical trial methodologies
- Examine the critical role of patient perspectives in shaping clinical protocols, identifying how patient input can enhance protocol design, improve engagement and shorten timelines
- Evaluate applications of generative AI in medical content creation
Speaker(s)
Impact of Decentralized Clinical Trial Methodologies on Protocol Planning and Development
Katie Kelm, PhD
PPD, Part of Thermo Fisher Scientific, United States
Associate Director, Global Medical Writing
Voices that Matter: Capturing Patient Input for Clinical Protocol Development
Leanne Woehlke, MA
TransPerfect, United States
Director, Life Sciences Solutions
Unleashing the Power of Generative AI in transforming Study Protocol Design and Medical Writing Process
Susant Mallick, MBA
Cloudhub BV, Netherlands
Founder and CEO, Life Sciences Practice Leader