When the CRO and Sponsor Speak the Same Language, Oversight Stops Being a Negotiation
Ed Fowler, Parexel's former Vice President of Operational Excellence, on what shared CTMS infrastructure has changed — and what...
The FDA Alignment Playbook Behind Ocular Therapeutix’s Single-Trial NDA
How Ocular engineered a retinal drug program backward from approval, and what that means for every sponsor still designing...
Pediatric Dermatology’s Blind Spot: How Arcutis Built a Drug Pipeline Where the Industry Wouldn’t Look
Frank Watanabe turned a clinician's frustration into a regulatory strategy that has now yielded seven approvals for ZORYVE. The...
Veeva’s eSource Isn’t Another Digital Layer. It’s the Last One.
Manny Vazquez and Denali Rose on why the industry's oldest data-entry problem is finally solvable and why sites have...
When Privacy Is the Product: How Albus Health Is Redefining What Clinical Trials Can Measure at Home
A contactless device, 40 countries, and a design philosophy that starts with patients — not compliance checklists The question...
After EVAR, the Aneurysm Sac Remains. Shape Memory Medical Is Running the First Randomized Pivotal Trial to Do Something About It.
With enrollment complete at 48 centers across three countries, CEO Ted Ruppel and VP of Marketing Mary Dennehy explain...
When the Site Is Also the Sponsor: Princess Máxima’s Rinke Riezebos on Data Standardization, Protocol Design, and Why Sponsors Should Listen to Their Sites
Princess Máxima Center for Pediatric Oncology is both sponsor and site, and that dual vantage point gives Rinke Riezebos...
The Standards Gap Is the Strategy Gap
Veeva's regulatory and policy leads on AI accountability, FDA uncertainty, and why fragmentation is the real competitive threat
Why AI Readiness Starts with the Digital Foundation
AOP Health's VP of Digital on why platform consolidation has to come before the AI conversation
The 95% Problem: Why Clinical AI Keeps Failing — And What It Takes to Actually Fix It
Medable's Andrew Mackinnon on agentic AI adoption, ontology layers, and why waiting to clean your data may cost you...