Premier Perspectives The blog for insider insights in clinical development Medical and Regulatory Affairs 4 Scenarios When High Risk Devices May Be Exempt from Mandatory Clinical Investigations Under EU MDR By Premier Research April 17, 2024 Featured Posts Clinical ResearchPhase 1 - Phase 4 Mastering Dose Escalation Studies Part 2: Charting a Clear Path from Planning to Execution By Ashley Herrick April 15, 2024 Medical and Regulatory Affairs Enhancing MedTech Patient Enrollment: The Value of a Recruitment Lead By Heidi Boehm April 9, 2024 Premier Voices Podcast Conversations with Premier's subject matter experts PREMIER VOICES #15 Enhancing Clinical Trial Accessibility – Bringing Oncology Trials to Patients PREMIER VOICES #13 Early-Phase Oncology – Emerging From the Crisis & Innovating for the Future PREMIER VOICES #12 Direct-to-Patient – Is This the ‘New Normal’ for Clinical Trials? PREMIER VOICES #11 Statistical Considerations in the Wake of COVID-19 PREMIER VOICES #10 COVID-19 Update – How the FDA's Emergency Use Authorization Can Help Develop Therapies Faster Premier Voices #8 Engaging Patients in Clinical Trials w/ Alan Thomas Premier Voices #7 Rare Disease Advocacy & International Ataxia Day w/ Alan Thomas (Ataxia & Me) Premier Voices #6 Operationalizing the New MDR With Janet Kube (Part 2) Premier Voices #5 Operationalizing the New MDR With Janet Kube (Part 1) Premier Voices #4 The Placebo Problem Part 2 With Michael Kuss 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 Safety First: Special Considerations for Medical Device Trials By Ewa Tomerska-Kowalczyk April 9, 2024 Clinical ResearchPhase 1 - Phase 4 Mastering Dose Escalation Studies Part 1: Optimizing Efficiency in Phase I Trial Execution Using Adaptive Design By Premier Research April 8, 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 Medical and Regulatory Affairs FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals By Charles Chrisawn March 6, 2024 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 5 Stages of Medical Device Development By Premier Research March 1, 2024 1 2 3 … 56 Next × 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