What are the main roles of a CRO in clinical trials?

CROs manage various aspects, including study design, regulatory submissions, patient recruitment, and data management, all while monitoring patient safety throughout the clinical process.

How do CROs ensure adherence to safety regulations?

CROs implement standard operating procedures (SOPs) in line with GxP (Good Practice) guidelines, ensuring compliance and safeguarding patient safety at every endpoint.

Why is patient safety crucial for regulatory submissions?

Regulatory agencies require comprehensive documentation of safety data to weigh the risks against the benefits of drugs. This is crucial in gaining approval for market access.