Archives: White Papers

Gene Therapy for Parkinson’s Disease: Strategies and Operational Requirements

The Changing Landscape of Psoriasis Treatment

Medical Device Development: Pathways to Clearance or Approval in the U.S. and Europe

Regulatory Challenges in Global CAR-T Cell Therapy Development

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Addressing a Critical Unmet Need: Considerations for Designing and Conducting Neonatal Clinical Trials

Understanding New FDA Guidance for Pediatric Oncology Studies: A Sponsor’s Guide to the FDA RACE for Children Act

Best Practices for Interventional Cardiovascular Medical Device Trials in Asia

Unlocking the Full Potential of Precision Medicine in Oncology

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight