Register Now: Beyond EDC: Designing a Connected Data Strategy for Predictive Clinical Development
News|Articles|November 4, 2026

De-Risking FIH: Integrated Strategies for Rapid Proof-of-Concept (Sept 2026)

First-in-human studies are often where promising programs encounter delays, uncertainty, and increased risk. This whitepaper examines strategies to de-risk early clinical development through integrated trial design, CMC planning, and streamlined execution, helping sponsors generate proof-of-concept data faster and make more confident development decisions.


Related to this article

© Grispb - © Grispb - stock.adobe.com
Mistral and OpenAI produced identical overall eligibility labels across 200 synthetic patient-study assessments, with criterion-level disagreements concentrated in inclusion criteria where models switch between “Uncertain” and “Not included” when records lack sufficient evidence, so model choice should be driven by deployment architecture, control, and cost rather than assumed interchangeability.
The Human Side of Clinical Trials: Before Burden Becomes Risk, Capturing Friction in Real Time
In Episode 4 of The Human Side of Clinical Trials, host Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., speaks with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about how capturing friction closer to the moment it happens can reveal unclear instructions, technology friction, and workarounds that retrospective surveys and debriefs tend to miss.