PUBLICATIONS

FDA Signals Shift Toward a One-Trial Default for Drug Approval FDA outlines a move toward one pivotal trial supported by confirmatory evidence. What this means for sponsors and clinical strategy. Read more

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy: A Turning Point for the AAV Field? The recent FDA rejection of Regenxbio’s gene therapy for Hunter syndrome (MPS II) is more than a single company setback. It is a signal, and the gene therapy sector should take it seriously. Read more

Oncology CRO: A Practical RFP Guide for Sponsors and Biotech Teams What You’ll Learn in This Article Table of Contents Key Challenges in Oncology Trials and What to Expect from Your Oncology CRO What to Really Look for in an Oncology CRO: 7 Sponsor-Centered Criteria That Matter How to Choose the Right Oncology CRO Actionable RFP Questions for Choosing the Right Oncology CRO Common Pitfalls in Read more

Why SCOPE 2026 Felt Different for Clinical Research By Nicole Brenna, US Business Development Director at Cromos Pharma  As the 17th annual SCOPE Summit wrapped up, the energy around clinical research was unmistakable. Over four days, sponsors, CROs, sites, and technology leaders came together, offering a clear view of where the industry is heading next. Compared to last year, the mood felt more optimistic, with budgets Read more