Quality Assurance

PRA's independent Quality Assurance team serves our clients in two distinct ways. First, as a standard part of how PRA operates, the Quality Assurance team helps ensure that our project teams deliver the highest level of services to you, our clients. Second, Quality Assurance provides a variety of services directly to clients through a team that includes physicians and pharmacists. Our management team averages 10 years of auditing experience and 18 years of industry experience. Our auditors are rigorously trained to audit for GCP (Good Clinical Practice) and we have auditors that also have expertise in GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) and in computer system validation and 21-CFR § 11.

PRA's Quality Assurance team has performed audits for a wide range of medical indications and in all phases of clinical trial. Based in North America and Europe our team have conducted audits on six continents and includes auditors fluent in:

• English
• French
• German
• Hungarian
• Polish
• Spanish
• Dutch
• Mandarin-Chinese

The QA team supports a variety of audit types as well as hosting and preparing for regulatory inspections. While hosting numerous inspections, we have worked in close collaboration with the Food and Drug Administration (FDA) and The European Agency for the Evaluation of Medicinal Products (EMEA).

Over the past two years, QA has conducted approximately 275 internal audits including site audits/CRA assessments, database audits and system/process audits. During that same period, PRA has hosted approximately 110 audits of PRA by sponsors. PRA's global Quality Assurance department is autonomous and independent of the personnel engaged in the direction and conduct of clinical trials.