Monitoring Services for Clinical Trials

Monitoring plays a central role in the correct development and quality of a clinical trial. Monitoring a clinical trial consists of verifying that the data entered in the electronic data capture (EDC) system are consistent with the source data found in the medical records at clinical sites and ensuring that the study procedures and tests are performed according to the protocol.

The persons in charge of clinical trial monitoring tasks are called monitors, also known as clinical research associates (CRAs). The CRAs are the main points of contact that provide support to the research teams located at clinical sites, also carrying out onsite monitoring visits.

Sofpromed is a clinical research organization (CRO) specialized in monitoring clinical trials, including the following services:

• Onsite and remote site qualification visits (SQVs)
• Onsite and remote site initiation visits (SIVs)
• Activation of participating clinical sites
• Site management (daily communication with the research teams)
• Onsite and remote interim monitoring visits (IMVs)
• Review of EDC data
• Onsite close-out visits (COVs)

Sofpromed’s monitoring services are offered for phase I to IV clinical trials, in most therapeutic areas. These services are designed to meet the needs of biotech and pharma companies as well as academic sponsors, running clinical studies in the United States, United Kingdom, Europe, and Asia-Pacific.