AFFORDABLE, QUALITY STUDY MANAGEMENT SERVICES FOR MEDICAL DEVICESClinical Trial Management | Clinical Monitoring | Data Management | Clinical Applications | FDA Audit Preparation

CLINICAL MONITORING

Sierra Clinical believes in building strong relationships with clinical study sites to ensure a site's commitment to a clinical study. Our monitors are experts in the unique requirements associated with medical device research. They have a vast understanding and training of GCPs in accordance with FDA regulations.

• Site selection & qualification
• Monitoring plan development
• Site initiation visits & training
• Interim monitoring visits
• Ensure protocol compliance
• Source document verification
• Query resolution
• Track & review study regulatory documentation
• Monitoring reports
• Close-out visits