Source: OmniComm Systems, Inc.
Challenges
- A midsize pharmaceutical company contracted a global CRO headquartered in Europe to conduct a global phase II study in infectious disease across 40 sites and 225 subjects.
- The molecules in clinical development were a breakthrough for the company and the stakes were high.
- Close monitoring of the scientific aspects as well as the operational performance of the study was essential.
- The client’s clinical team didn’t have processes or procedures to formally implement RBM.
- Limited additional budget.
