Premier Perspectives The blog for insider insights in clinical development Recent Posts By expertise area All expertise areas Medical DeviceRare DiseaseOncology & HematologyDiagnosticsDigital TherapeuticsMedTechPediatricsNeuroscienceAnalgesiaDermatologyOtherCOVID-19Cell & Gene TherapyWomen's HealthReal-World & Late PhaseCareers By functional area All functional areas Development StrategyClinical Research: Phase 1 - Phase 4ConsultingData Management & BiostatisticsFunctional Service Provider (FSP)Global ComplianceMedical and Regulatory AffairsPatient and Stakeholder EngagementProject ManagementQualityReal-World Science and Late PhaseSafety/PharmacovigilanceStudy DesignStudy Start-UpOtherCOVID-19Product Development Medical and Regulatory Affairs Medical Device Trials: What You Need to Know About U.S. Regulations By Premier Research June 22, 2018 Consulting Planning a Gene Therapy Trial? Ask an Expert — and Pay Attention By Premier Research June 20, 2018 Clinical ResearchPhase 1 - Phase 4 Tackling Common Issues in Gene Therapy Trial Operationalization By Premier Research May 31, 2018 Medical and Regulatory Affairs The Guardrails of GMOs: Regulatory Considerations for Gene Therapy Trials By Premier Research May 25, 2018 Clinical ResearchPhase 1 - Phase 4 Gene Therapy 101: From the 1960s to Today By Premier Research May 18, 2018 Medical and Regulatory Affairs Are You Ready for the FDA’s eCTD Filing Deadline? That’s May 5, 2018. Yes. Tomorrow. By Premier Research May 4, 2018 Previous 1 …6 7 8 9 10 … 17 Next × ALSO OF INTERESTResource Document: 8 New Elements of the IVDRThe Placebo Problem, Part 8: Finding Another WayBio International