Clinical Monitoring

Effective Clinical Monitoring forms the backbone for the efficient execution of a Clinical Trial. We firmly believe that robust clinical monitoring is vital to a clinical trial to yield valid regulatory acceptable clinical data. At Vibgyor, our CRAs are well-trained and experienced to ensure high-quality data review and effective communication with study sites and sponsors. Our CRAs receive comprehensive and continued on-the-job training through our internal training and development program that helps them develop a deep understanding of each protocol, standard operating procedures (SOPs), and gain a thorough knowledge of ICH-GCP and all applicable regulatory guidelines.

Our clinical monitoring services include:

• Investigator Identification and Site selection
• Site Qualification Visits
• Planning and executing Investigator Meetings
• Site Initiation Visits and Site staff Training
• Informed Consent Form review
• Interim and Routine Monitoring Visits
• Source data verification and CRF data review
• Monitoring Adverse Event reporting
• Performing drug and/or device accountability.
• Patient unblinding
• Ensuring regulatory compliance
• Close Out /Study Termination Visits