Quality & Compliance
From initial planning to your final report, our quality experts will support compliance, efficiency, and reliability from start to finish.
Overview
Premier Research is dedicated to ensuring that your clinical trials meet the highest standards of quality and compliance. Our experienced team will guide you through every step, implementing best practices and processes that streamline your clinical research, minimizing risks, and optimizing outcomes.
With our knowledge of international regulatory guidelines, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs), we conduct thorough reviews and audits to identify potential issues before they affect your trial. In addition, we’ll support you in developing and reviewing processes and materials and preparing for inspections.
Our services include:
- Investigative site audits
- Trial master file audits
- Database audits
- Clinical study report audits
- Statistical report audits
- Vendor and supplier audits
- Issues management (Investigations, deviations, CAPAs, OOS,
- Quality management system (QMS) development
- Preparation/revision of corporate SOPs
- Establishment of quality agreements and manuals
- Inspection readiness training
Integrations
Creative strategic solutions to overcome complex challenges and accelerate development
Industry leaders with comprehensive submission experience position your product strategically
Expert study design, optimized data collection, and comprehensive insights
Ensure safety through all stages of clinical development
Integrated, technology-enabled approach to drive efficiency and quality across clinical development
Managing & delivering every study with your business priorities in mind
Insights
Agility and knowledge at your fingertips
5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights
How to Navigate Global Regulatory Frameworks & Expedited Programs for Gene Therapy Development in the U.S., EU, & Japan
resources
Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.
Ready to get started? So are we.
Drop us a line to learn more about how we can help.