Medical Affairs and Scientific Communications Forum

3 Tracks (Medical Communication, Medical Writing, and Field Medical) + 1 Location = A cross-functional experience for knowledge sharing, integrated thought leadership, and proactive networking.

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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

Entrada Ventures, United States

Executive Vice President, SOGLIA

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