Site Monitoring

Oncology clinical trials require experienced and educated teams to monitor the trials. Prologue's team of clinical research associates (CRAs) is experienced in the oncology therapeutic area and will expertly monitor your clinical data. In fact, all CRAs are required to have at least 2 years oncology monitoring experience before being considered for employment. Our CRAs are also extensively trained in GCP/ICH guidelines and FDA regulations for clinical research.

CRAs will assess and educate site personnel and ensure that the clinical data collected are of the highest quality. The CRA team will also work closely with project and data management, and other functional groups, to be proactive about site issues, including CRF completion, regulatory document retrieval, and patient safety.

Clinical monitoring activities include:

• Site identification
• Site qualification and initiation
• Regulatory document collection
• Investigator meeting planning and presentation
• Site personnel training
• Interim site monitoring
• Site termination
• Clinical product accountability