Archives: Premier Insights

Premier Insight #288 | The path to approval: Achieving FDA clearance for a ground-breaking dermatology product

Premier Insight #287 | When an “Untreatable” Condition Finds Its Voice

Premier Insight 286 | Seamless Transitions: Navigating a Sponsor Change During an Ongoing Oncology Clinical Trial Program

Premier Insight 285 | When Regulatory Meets Operations: FIH Gene Therapy Study Hits Milestone Despite IND Challenges

Premier Insight 284 | Leveraging Experienced Research Networks for Global Psychiatry Studies in Difficult-to-Access Populations

Premier Insight 283 | Rescuing a Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum

Premier Insight 282 | Leveraging the Power of Communication: Supporting Enrollment of a Phase 2 Cervical Cancer Study During a Pandemic

Premier Insight 281: Overcoming Enrollment Challenges in a Phase 2 Prostate Cancer Clinical Trial

Resource Document: 8 New Elements of the IVDR

Premier Insight 278: A Decade-Long Partnership Culminates in FDA Approval