
Metrics & Benchmarks
Latest News

Is Decentralization Actually Reducing Site Burden, or Just Moving It?

DPHARM 2026: The Patient Journey Gap That Study Design Still Hasn't Solved

ACT Brief: Patient-Site Interaction and Technology, AI Pilot Success Requires Discipline, and CagriSema Beats Lilly Drug

Moving Beyond Disappointing Pilots: Scaling Adoption of AI-Enablement in Drug Development

DPHARM 2026: Why Making Technology Easier Isn't Enough for Sites

Shorts










Podcasts
Videos
All News

In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a gene therapy for a rare childhood syndrome.

In a video interview prior to the 2026 DPHARM conference, Andrea Valente, CEO of uMotif, shares what she expects to be at the center of the conversation—from building trust between patients and sites to where AI may and may not have a role in that relationship.

A platform-based approach connects AI across workflows, data and governance, helping life sciences organizations move from isolated wins to real scale.

In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.

The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.

Why clinical development’s next AI bottleneck is not the model, but the system around it.

In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.

FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines
The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.

A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.

Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.

This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, outlines what it takes to move beyond transactional engagement and treat patient advocacy organizations as long-term partners in the science and the care.

In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.

As the life sciences industry continues to evolve, the ability to effectively manage and leverage preclinical CRO partnerships is set to become a defining characteristic of successful biopharma companies.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, shares what she has learned firsthand from families living with Dravet syndrome and CDKL5 deficiency disorder about what makes trial participation possible—and what makes it not.






















