Optimizing post approval research

A large global Pharma company was required to run a complex global safety study by regulatory authorities. This was a crucial study to ensure that patients were not exposed to risk.

This large Pharma company was facing a restriction in use of its blockbuster drug following reports of a safety problem. The company identified and addressed the source of the problem but were required to carry out a Post Approval Safety Study to prove that this low incidence, high risk problem was resolved. The study needed to be built and initiated quickly and it needed to drive a regular through put of high quality data to facilitate regular and accurate interim reports to Licensing Authorities.

Cisiv was able to build a study in 10 weeks and launch it across 21 countries. The data demonstrated that, in its new formulation, the product was safe and the study was closed early in agreement with the licensing authorities, saving the sponsor significant time and effort and enabling sales growth.