Supporting Compliance, Efficiency, and Safety From Start to Finish

As the global regulatory landscape evolves and data sources multiply, the stakes for ensuring patient safety, regulatory compliance, and data integrity are higher than ever. With deep expertise in international guidelines and all areas of good practices (GxPs), Premier Research helps ensure your clinical trials meet the highest standards—minimizing risk and optimizing outcomes.

Comprehensive GxP Compliance Support

From early-phase development to inspection readiness, our experts offer full-service, project-based, and consulting support tailored to your needs.

Quality Processes and Systems

We’ll define your quality process, draft materials, and develop your QMS, giving you peace of mind as your program progresses:

• Issue management (investigations, deviations, CAPAs)
• Quality Management System (QMS) development (preparation/revision of corporate SOPs aligned with product lifecycle)
• Quality agreements and manuals
• Facility design and validation

Audits and Reviews

We conduct comprehensive, SOP-driven audits to uncover potential issues before they impact your study, with experience across:

• GxP audits: vendors, suppliers, study sites
• Trial Master File (TMF) audits
• Database, clinical study report, and statistical report audits
• Vendor qualification and selection
• QA review of batch records, specifications, test methods, validations, and stability protocols

Inspection Readiness and Regulatory Training

Prepare your team for regulatory success with targeted, hands-on training informed by real-world FDA and global inspection experience:

• Instructor-led training courses
• Site assessments
• Mock inspections

Your Partner for Unbiased and Strategic Support

At Premier, we deliver unbiased, strategic quality and compliance support to ensure audit readiness, data integrity, and regulatory confidence. Contact Premier today to discuss how we can strengthen quality across your development program.