US-based contract research organisation (CRO) PRA International has opened a Drug Safety Center at its office in Sao Paulo, Brazil, reinforcing the company’s Latin American presence and extending a network of dedicated drug safety centres already established in Charlottesville, US and Mannheim, Germany.
PRA has hired and trained drug safety professionals for the Sao Paulo centre and is already executing safety project work from the site, the CRO said, adding that it would continue to expand its global safety management offerings.
“This new centre will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base,” commented Dr Sabine Richter, vice president of safety and risk management.
The Drug Safety Centers are a key component of PRA’s Safety and Risk Management unit, which offers a comprehensive range of services throughout a product’s lifestyle, the CRO noted.
In 2008 alone, PRA completed more than 18,000 individual safety reports, 3,000 expedited and 250 cumulative safety reports to regulatory authorities, and five data integration and pooled analysis projects, as well as hosting 21 client pharmacovigilance audits and contributing to three US Food and Drug Administration approvals.
“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,” said Steve Powell, senior vice president, clinical informatics and late phase services.
