Site Monitoring

 Site Monitoring


Monitoring is one of the most critical aspects of a clinical trial. Our monitors are experienced in performing site monitoring visits (PSSV to SCV).They undergo an in-house CRA workshop, which is solely focused towards the quality of monitoring, report preparation, pre-requisites for monitoring etc. Our team diligently follows the norms decided for monitoring report quality and TAT.

Our monitors are trained to be site auditors, where they methodically scrutinize the site, and identify issues (if any) on real time basis, and work towards resolution and preventive action. They are equipped in performing all the site monitoring related activities as mentioned below (but not limited to):

  • Source data verification
  • Review of Investigator site file for legibility, completeness and accuracy
  • Site staff training
  • Assist in EDC data entry and query resolution
  • IP accountability
  • Study materials supply management
  • Review of consenting process
  • Identify protocol deviations, if any, and perform CAPA as deemed fit
  • Review and follow up of adverse events and concomitant medications
  • Document the visit through confirmation letter, detailed monitoring visit report and follow up report

We also perform risk-based analysis of the sites’ data, and based on the outcome, recommend Sponsor for onsite or remote monitoring.

Monitoring, ClinPro Research