A large global pharma company was required to run a complex global safety study by the regulatory authorities. This was a crucial study to ensure that patients were not exposed to risk.
Cisiv built a study in 10 weeks and launched it across 21 countries. Using Baseline Plus we were able to deal with complex data capture, analysis and reporting to various licensing authorities. As a result, the data was collected and reported faster than expected, and the study closed early, proving that patients were not at risk. Cisiv’s technology saved the Sponsor significant costs and effort and helped them to maintain sales growth.
Background
The large pharma company was facing a restriction in the use of its blockbuster drug following reports of a safety problem. The company identified and addressed the source of the problem but was 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 throughput of high-quality data to facilitate regular and accurate interim reports to licensing authorities. It had to embed safety reporting and safety follow-up forms and processes to enable a rapid response to any potential safety issues.
Solution
Cisiv built the study in 10 weeks for immediate launch across 21 countries. The study platform included Cisiv’s safety reporting system, which embedded the company’s safety SOPs and forms, including adverse event follow-up, and features to identify and manage suspected adverse events early in the data entry process. Baseline Plus supported quarterly reporting to licensing authorities. The data entry workflow, designed for non-interventional research, drove a steady flow of data through the system, making it available for interim analyses with minimal data cleaning.
Outcome
The data demonstrated that, in its new formulation, the product was safe, and the study was closed early in agreement with the licensing authorities. This saved the sponsor significant time and effort and enabled sales growth.
