Quality Assurance Services

PRA's Quality Assurance team performs audits of Phase I to Phase IV clinical studies for our clients. Our audit services include:

• Protocol & CRF Audits
• Trial Master File (TMF) Audits
• Investigator Site Audits
• Database Audits
• Clinical Study Report Audits
• System Audits (Quality Management Systems, SOP compliance)
• Pharmacovigilance Audits
• Mock Inspections
• Vendors of critical services - Capability or performance audits:
  • Clinical supply packaging/labeling/distribution
  • Central Readers
  • IVRS, e-CRF and remote data entry systems
  • Clinical and bio-analytical labs

All audits are performed to assess and ensure compliance with:

• Appropriate Standard Operating Procedures (SOPs)
• International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH GCP)
• Study protocol
• Client instructions
• Contractual obligations

In addition to audit services for our clients, Quality Assurance reviews and approves PRA SOPs. We review SOPs at least annually to ensure that they accurately reflect current practice, GCP and meet regulatory requirements. PRA employees and sponsors also utilize Quality Assurance as a GCP resource to respond to compliance questions.

The Benefits of PRA's Quality Assurance Group to Sponsors

PRA funded nearly 75% of the 427 audits performed by Quality Assurance in 2007. Many of these audits focused on PRA performance against GCP, contracts and PRA SOPs. The remaining audits studied the performance or capabilities of vendors and clinical investigators. Quality Assurance reviews all findings and responses for audits of PRA and clinical investigator sites. All audit findings, including those performed by client or contract auditors, are tracked in an internal database. This robust system facilitates trend analysis and root-cause analysis resulting in appropriate corrective actions.