Global Quality and Compliance
Quality Is non-negotiable
When it comes to the conduct of clinical trials, quality and compliance are nonnegotiable requirements in every step of the process. Risks threaten the most well-planned drug development. The PPD™ clinical research business of Thermo Fisher Scientific offers quality services to support and enhance the robust clinical activity for which we are known. Our global quality and compliance (GQC) services are delivered by trained professionals who have honed their expertise over decades of experience. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. We also help clients protect research subjects’ rights and welfare.
Comprehensive and client-specific expertise
We listens to clients’ concerns and tailors the delivery of expertise to meet their needs. Services are contracted and performed per standard operating procedures, or as defined by projects.
This can include:
- Auditing processes, clinical trial sites, labs, vendors and pharmacovigilance activities
- Examining report design and data analysis of audit metrics
- Pre-inspecting activities, mock inspections and follow-up support
- Developing risk management frameworks to escalate quality concerns
- Implementing and managing CAPA system
- Investigating suspected scientific misconduct
- Advancing standards/systems for procedural document management and control
- Progressing quality agreements and conduct of quality council meetings
- Training on how to host regulatory authority inspections
- Analyzing training for standardization into core curricula
- Creating and maintaining product specification files
- Coordinating identification testing for product import into the European Union
- Evaluating software vendors
- Assessing FDA 21 CFR Part 11
- Expanding or maintaining retention schedules
- Due diligence processing prior to disposition of business records
