Quality Assurance (QA) lies at the foundation of good clinical research.  That’s why PharmaNet takes pride in our excellent reputation in the field of QA as applied to our own clinical development services or to our comprehensive QA service offering to pharmaceutical and biotech companies.
 
Since objectivity is critical to fulfill the complex role of quality assurance professionals, PharmaNet ensures we conduct unbiased assessments by separating the roles of QA from the operational reporting structure. Our auditors offer this same impartiality for your studies and can enhance your compliance efforts.
 
Our QA team consists of nineteen senior auditors with expertise in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) with an average of twelve years industry experience. PharmaNet auditors are located throughout the United States, Canada, Argentina, United Kingdom, Germany, Russia, and Sweden. We have conducted audits in forty-five countries including the regions of the Americas, Eastern and Western Europe, Asia-Pacific, and Africa. What’s more our staff can conduct business in multiple languages.
 
PharmaNet Global Quality Assurance Services include:

Audit services for:  Investigator sites  Clinical and analytical laboratories  Drug packaging and distributors  Institutional Review Boards  Phase I Units  Suppliers/vendors  Sites and laboratories in developing countries to assess readiness  to conduct clinical trials

Validation services for:  Computer systems  Databases  SOPs

Specific QA of study deliverables including:  Protocols  CRFs  Clinical Study Reports  Study Files  Tables and Listings

Regulatory inspection preparedness and response services  SOP development  Assist with FDA and MHRA mock regulatory inspections  Training to prepare investigator sites for actual regulatory inspections  Assist preparing responses to FDA 483s

For more information:

In the Americas
Martin Valania
Vice President, Quality Assurance
609 951 6690

In Rest of World
Alec Deighton
Senior Director, Quality Assurance and Compliance
44 1494 896 270