A multinational pharmaceutical company asked us to help evaluate the safety and efficacy of their product in patients with unresectable hepatocellular carcinoma (HCC) regionally and globally under real-life conditions. We were also asked to track/evaluate treatment and morbidity patterns of this patient group.
We delivered a multilevel approach, starting with a non-interventional study of HCC spanning 3,000 patients in 45 countries worldwide. This study used a multilingual case report form. Data was collected via EDC using our flexible web-based project management tools, InDrums and Intrial, and paper-based CRF drawing upon our expertise in data management and biostatistics.
We worked in partnership with local teams from the client’s head offices, helping them develop appropriate processes. Over 50 on-site monitoring visits were arranged.
The resultant database was the largest prospective HCC database to date, which provided the client with data that will guide treatment decisions for years ahead. Combined with our adeptness in oncology, data management skills and knowledge of global requirements, this meant the study could be extended to other countries.
By seamlessly garnering our span and depth of expertise across geographies and methodologies we harnessed local insight to create a global treatment database of patients with this devastating disease. This has helped inform the client’s risk management processes to such an extent that we have been continuously engaged on the project to provide additional help and support around the core database.