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PRA International Opens Additional Drug Safety Center in Sao Paulo, Brazil

Posted on: Wednesday, 27 May 2009, 08:00 CDT

RALEIGH, N.C., May 27 /PRNewswire/ -- PRA International, a leading Clinical Research Organization, announces the opening of a Drug Safety Center in its Sao Paulo, Brazil office. Drug Safety Centers are a key component of PRA's Safety and Risk Management unit. They are staffed with drug safety professionals who are responsible for Serious Adverse Event and Adverse Drug Reaction management. Furthermore, our drug safety personnel support our clients in all other aspects of pharmacovigilance to ensure regulatory compliance.

PRA already operates two dedicated Drug Safety Centers, one in Charlottesville, VA, US and the other in Mannheim, Germany. The opening of the Drug Safety Center in Sao Paulo strengthens PRA's footprint in Latin America and provides additional global reporting capabilities. With drug safety professionals hired and trained, PRA is already executing safety project work from the Sao Paulo center and will continue to expand its global safety management offerings.

"The opening of the Sao Paulo Drug Safety Center enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardized Drug Safety services globally, by growing and strengthening our overall safety team," noted Dr. Sabine Richter, PRA's Vice President of Safety and Risk Management. "This new center will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally."

"The growth of our drug safety services in Latin America is a component of PRA's continued global expansion to best support the new dimensions of drug development," added Steve Powell, Senior Vice President, Clinical Informatics & Late Phase Services. "PRA is committed to long-term patient safety and understands the increasing focus of regulatory bodies and in turn of our clients on the benefit risk profiles of medicinal products. PRA's expansion not only increases our breadth geographically, but also strengthens the depth of the services we provide to sponsors and patients."

PRA's Safety and Risk Management team offers comprehensive services throughout a product's life-cycle. PRA provides services to support EU-RMP, FDA-REMS, Annual Safety Reporting, IND Reports and a host of other services. In 2008 alone, PRA accomplished the following for its clients:

• More than 18,000 individual safety reports
• 3,000 Expedited Safety Reports to regulatory authorities
• 250 Cumulative Safety Reports to regulatory authorities
• 5 data integration and pooled analysis projects
• Hosted 21 client pharmacovigilance audits
• Contributed to 3 FDA Approvals

About PRA International

PRA International is a global Clinical Research Organization providing services through all phases of clinical development. We perform studies in all therapeutic areas, with specialization in Oncology, Neurosciences, Respiratory/Allergy, Cardiovascular and Infectious Diseases. PRA has supported over 2,100 clinical trials through its 35 global offices. PRA's therapeutic expertise, global reach and project experience, combined with extensive local knowledge and our differentiating PERSONAL ELEMENT enable our project teams to deliver consistent and on time performance for our clients. This unique PRA philosophy - THE PERSONAL ELEMENT - recognizes that true client service comes only from trained, empowered and dedicated employees who are encouraged to use innovation and their personal commitment to accelerate the development lifecycle.

To learn more about PRA International, please visit http://www.prainternational.com, email endpoints@praintl.com or call our Global Headquarters at +1 (919) 786-8200.

SOURCE PRA International

Source: PR Newswire

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