Perspectives

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perspectives

September 29th, 2026

Getting to First-in-Human Faster: What FDA’s New IND Pilot and NAMs Shift Mean for Sponsors

perspectives

September 21st, 2026

From Data to Decisions: Evaluating Bayesian Dynamic Borrowing Before Your Trial Begins

perspectives

September 11th, 2026

Navigating the Future of Clinical Trial Transparency: Balancing AI-Driven Anonymization with Human Oversight 

perspectives

September 3rd, 2026

From Signal to System: FDA Approval Does Not Mean Treatment Can Begin the Next Morning

perspectives

August 27th, 2026

Risk-Based Data Management: Moving Beyond Traditional Data Cleaning

perspectives

August 17th, 2026

From Signal to System: The Evidence Questions Psychedelic Therapies Must Answer

perspectives

August 11th, 2026

The Race to Faster Drug Development: A Quicker On-Ramp Doesn’t Help If You’re Headed the Wrong Way 

perspectives

August 7th, 2026

UK Clinical Trial Transparency Changes for Phase I Studies: What Sponsors Need to Know

perspectives

July 31st, 2026

FDA Orphan Drug Designation Requirements: Key Mistakes to Avoid

perspectives

July 29th, 2026

From Signal to System: The Next Challenges for Psychedelic Therapies

perspectives

July 24th, 2026

FDA’s Latest Psychedelic Guidance: Key Changes and Implications for Sponsors

perspectives

July 7th, 2026

Don’t Veer for Deer: Why Drug Development Needs Steady Steering in the Age of AI and Real-Time Data