
Metrics & Benchmarks
Latest News

DPHARM 2026: What the Patient-Site Relationship Needs Most Right Now

How a Platform Approach Can Scale AI’s Impact in Life Sciences

ACT Brief: Patient Voice as Methodology, AI System Bottlenecks, Regulatory Convergence on Patient Input

What "Patient Voice" Actually Requires: Beyond the Buzzword

Lessons from Hundreds of Clinical Trials: AI’s Successes, Gaps, and Opportunities

Shorts










Podcasts
Videos
All News

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.

In today's ACT Brief, we examine how shifting patient engagement to endpoint selection improves trial data quality, why execution infrastructure must precede AI deployment, and addressing missing baseline data in real-world oncology research.

Clinical trials have spent decades perfecting data capture, but the execution layer underneath it, including decision workflows, data collection design, and lab connectivity, remains fragmented in ways that limit what AI can realistically deliver and that quietly compromise the scientific validity of the data itself.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, describes how shifting patient engagement from protocol review to endpoint selection transforms both the quality of trial data and the experience of participation.

In today's ACT Brief, we examine why seizure reduction misses what families want from epilepsy trials, how lab coordination requires connecting data to intent, and why healthcare needs orchestration rather than more tools.

True lab orchestration isn't about coordinating instruments, it's about connecting scientific intent, data, and decisions across the entire research lifecycle.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, explains why the full burden of developmental and epileptic encephalopathies extends far beyond clinical symptoms—and why endpoints must reflect what families are actually hoping for.






















