Case Studies
Cmed’s Mobile Data Management Solution
Company A were obliged by the FDA to provide supplementary data on cardiac safety, specifically to find the maximum tolerated dose before QTC levels became unsafe. The study was placed in a specialist Phase 1 unit with no previous EDC experience and limited access to the internet.
Challenges of non-CRF data in oncology studies
96 sites with local laboratories using site specific normal ranges?
9 different types of external data required in the study? Could you cope? Cmed CS did.
Project Recovery (Rescue) from another CRO.
As the study unfolded it became apparent that the data being collected would support a pivotal study, thus outstripping the capabilities of the locally selected CRO. Cmed CS were invited to rescue all data management responsibilities and as well as adhering to all reporting timelines were able to streamline the external data review process by providing the DSMB with real-time access to the database.
