From the centre PRA will provide services support clients activities including assistance with US Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy (REMS) and annual safety reporting.
PRA already provides these services from its sites in Charlottesville, Virginia, US and Mannheim, Germany but the company regards the opening of the Brazil centre as an important step in expanding its global footprint.
Sabine Richter, PRA’s vice president of safety and risk management, said: “The opening of the São Paulo drug safety centre enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardised drug safety services globally, by growing and strengthening our overall safety team.
“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. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally.”
The centre is staffed with drug safety professionals and has already commenced activities, with the team drawing on expertise from other groups in PRA, such as “analysis & reporting” and “late phase services”.
This follows the model of the exiting facilities in Germany and the US, which in 2008 did more than 18,000 individual safety reports, five data integration and pooled analysis projects and contributed to three approvals by the FDA.