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Where Oncology Programs Actually Die: The Four Enrollment Bottlenecks
Most oncology clinical trials that stall or fail do so because they cannot enroll the right patients fast enough — not because the molecule was
The 30-Day Myth: Why “FDA Approval” of Your IND Doesn’t Exist
There is no FDA “approval letter” for an Investigational New Drug application. Under 21 CFR 312.40(b)(1), your IND goes into effect 30 days after the FDA receives
How to Run a Clinical Trial in India: A Step-by-Step Guide for U.S. Sponsors
Running a clinical trial in India as a U.S. sponsor comes down to five decisions, made in the right order: get the regulatory
The Full-Service CRO Model Is Being Stripped for Parts. Here’s Who’s Doing the Stripping
Last quarter, a top-20 pharma company pulled biostatistics, data management, and pharmacovigilance out of a $400 million full-service CRO model. Kept the CRO
FDA Just Killed the Two-Trial Rule. Most Sponsors Haven’t Noticed Yet.
February 2026. A 47-page draft guidance drops on the FDA website. No press conference. No industry call. Just a PDF that rewrites the
AI in Clinical Trials Moved From Pilot to Production — And Most Sponsors Aren’t Ready
AI in Clinical Trials Moved From Pilot to Production — And Most Sponsors Aren’t Ready A VP of Clinical Operations spent $2.4 million
The CRO You Hired in 2023 Isn’t the CRO You Need in 2026 — How the Outsourcing Model Is Breaking
The CRO You Hired in 2023 Isn’t the CRO You Need in 2026 — How the Outsourcing Model Is Breaking Your CRO contract
FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission
FDA’s Real-World Evidence Shift Is Bigger Than You Think — What It Means for Your Next Submission In December 2025, the FDA finalized
Why 85% of Clinical Trials Miss Enrollment Targets — And What Your Site Selection Strategy Is Getting Wrong
Why 85% of Clinical Trials Miss Enrollment Targets — And What Your Site Selection Strategy Is Getting Wrong The brutal statistics have barely
