A large pharmaceutical organization (the sponsor) was working with multiple Clinical Research Organizations (CROs). Each CRO had its own Clinical Trial Management Systems (CTMS) implementations such as Veeva, configured to suit their internal best practices; the sponsor also had 4 CTMS systems in their environment. 

Recently, the sponsor adopted CluePoints - a Risk Based Quality Monitoring (RBQM) platform. Data from the clinical trial systems needs to be loaded to CluePoints for anomaly detection, and signal generation. Central Monitors and study teams then generate issues in CTMS. The actions taken because of those issues are returned to CluePoints. If the sponsor and a single CRO were involved, this could have been addressed through a direct API and middleware integration between the two systems - though in practice, even such point-to-point integrations typically require several months of effort to design, validate, and deploy. However, in this case, there were multiple CROs and multiple CTMS implementations, which meant differing system configurations and data formats.

The sponsor required a bi-directional integration between the various CTMS implementations and CluePoints. They needed the ability to manage multiple CTMS implementations in an automated and error-checked manner across both CluePoints and the CTMS instances. Scalability was essential – the sponsor may adopt additional CTMS solutions in future, and needed a flexible integration approach that minimized overhead when adding new systems.