Premier Perspectives The blog for insider insights in clinical development Understanding the Patient Perspective in Rare Diseases: Asking the Right Questions By Premier Research September 6, 2024 Featured Posts Harnessing the Power of Clinical Data with Post-Market Clinical Follow-Up Activities By Caroline Perez August 27, 2024 Consulting Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development By Jayesh Patel August 12, 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 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 Clinical ResearchPhase 1 - Phase 4 Navigating Uncertainty with Confidence: Bringing In Vitro Diagnostics to Market in the EU By Charles Chrisawn August 5, 2024 Clinical ResearchPhase 1 - Phase 4 The New Normal for Laboratory Developed Tests: Recent Changes to FDA Regulation By Charles Chrisawn July 23, 2024 Development Strategy Avoiding 3 Common Pitfalls to Efficient Site Selection By Nicole Stansbury July 16, 2024 Clinical ResearchPhase 1 - Phase 4 FDA’s Diversity Mandate: Transforming Clinical Trials and Drug Development for Better Outcomes for All By Premier Research July 10, 2024 Consulting The New Drug-Drug Interaction Guidance, ICH M12: How to Accelerate Your Drug Development Program By Madelyn Huang July 8, 2024 Medical and Regulatory Affairs Bringing Drugs for Depression to Market: US and EU Regulatory Frameworks By Adam Simmons June 19, 2024 1 2 3 … 59 Next × ALSO OF INTEREST7 Questions About Clinical Evaluations for MDRNostalgia or Shell Shock? Assessing PTSD Is a...Designing Pediatric Analgesic Treatment...