At DP Clinical, all projects must meet the highest quality standards, and that’s why we take a holistic risk-based approach to quality assurance. Our Quality Assurance team is an independent group that promotes excellence by ensuring adherence to our processes, applicable regulations, Good Clinical Practices (GCP), and Good Manufacturing Practices (GMPs). It starts with creating and implementing company-wide quality assurance policies and procedures and a robust Quality Management System (QMS) that govern everything we do. This enables early detection of potential problems and facilitates intervention and implementation of appropriate corrective and preventive actions when necessary to correct and prevent recurrence and allow for continuous improvement.
Training new staff and continuing education for veteran staff instill the deep-seated value of quality in our team. Included in DP Clinical’s mandatory employee training are the Corrective and Preventive Action Plan (CAPA), Good Clinical Practice, Human Subject Protection, and identification and handling of fraud and misconduct.
DP Clinical’s quality assurance services include:
- GCP and GMP auditing and/or compliance assessments (due diligence) of vendors, clinical sites, computer systems
- eTMF audits
- Standard Operating Procedure (SOP) preparation and compliance
- Quality Management System (QMS) implementation
- Risk management
- GCP and GMP compliance consulting
- Compliance training
- Inspection readiness/FDA mock inspections
- Supply Chain Management/Consulting
- Computer System Validation Compliance
- Regulatory training and education
