Premier Perspectives The blog for insider insights in clinical development Clinical Research: Phase 1 - Phase 4 Navigating Uncertainty with Confidence: Bringing In Vitro Diagnostics to Market in the EU By Michael Edwards August 5, 2024 Featured Posts Clinical ResearchPhase 1 - Phase 4 The New Normal for Laboratory Developed Tests: Recent Changes to FDA Regulation By Michael Edwards July 23, 2024 Medical and Regulatory Affairs Medical Device and IVD Insights: Mastering the 7 Steps of the CE Certification Process By Michael Edwards March 25, 2024 Recent Posts By expertise area All expertise areas Medical DeviceRare DiseaseOncology & HematologyDiagnosticsDigital TherapeuticsMedTechPediatricsNeuroscienceAnalgesiaDermatologyOtherCOVID-19Cell & Gene TherapyWomen's HealthReal-World & Late PhaseLife at Premier 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 Consulting Getting the Support You Need at Every Step of the CE Marking Process By Michael Edwards March 5, 2024 Clinical ResearchPhase 1 - Phase 4 A Different Pace: Meeting the Demands of Liquid Biopsy Development for Early Cancer Detection By Michael Edwards July 18, 2023 Clinical ResearchPhase 1 - Phase 4 It’s Better for Everyone: The Promise of Liquid Biopsy as a Cancer Screening Tool By Michael Edwards July 17, 2023 × ALSO OF INTERESTKey Considerations When Designing a Phase 1...Nostalgia or Shell Shock? Assessing PTSD Is a...Gene Therapy 101: From the 1960s to Today
