Premier Perspectives The blog for insider insights in clinical development Clinical Research: Phase 1 - Phase 4 Leveraging Real-World Data & Real-World Evidence to Support Regulatory Decision Making By Nach Davé October 3, 2022 Featured Posts Clinical ResearchPhase 1 - Phase 4 A Fit-for-Purpose Path Forward: Linking RWD to Your Overall Data Strategy By Nach Davé September 26, 2022 Clinical ResearchPhase 1 - Phase 4 What is Real-World Data and Evidence and How It Can Facilitate Clinical Development By Nach Davé September 19, 2022 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 Clinical ResearchPhase 1 - Phase 4 8 New Elements of the IVDR — and How to Change Your Approach By Nach Davé March 7, 2022 Study Design Compensating for the Unknown: 3 Keys to Implementing a Successful Decentralized Clinical Trial By Nach Davé May 13, 2021 Consulting Entering a New Clinical Phase of Non-Traditional Data Sources By Nach Davé September 30, 2020 Clinical ResearchPhase 1 - Phase 4 Premier Presentations from WODC By Nach Davé September 16, 2020 Consulting Can Your Clinical Data Strategy Keep Pace? By Nach Davé September 3, 2020 Data Management & Biostatistics Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm? By Nach Davé May 26, 2020 1 2 3 Next × ALSO OF INTERESTKey Considerations When Designing a Phase 1...7 Questions About Clinical Evaluations for MDRNostalgia or Shell Shock? Assessing PTSD Is a...
