The Stakes Were High In This Phase II Study, But The Risk Was Under Control

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.