Clinical Study Monitoring
Ensuring protocol adherence, data integrity, and regulatory compliance throughout study execution.
Clinical Study Monitoring Activities : Independent oversight for high-quality data and risk identification.
Our Clinical Study Monitoring services provide independent oversight to ensure that all participating sites operate in full compliance with study protocol, defined procedures, and applicable regulatory requirements. Through structured on-site monitoring, we support high-quality data collection, early identification of risks, and consistent study execution across sites.
Site Initiation Visits (SIVs)
- Conducting on-site SIVs to confirm site readiness prior to study start
- Training investigators and site teams on protocol, CRFs, and source documentation
- Verifying availability of required study documents, infrastructure, and approvals
- Ensuring uniform understanding of the study processes across all centers
Clinical Trial Monitoring Visits
- Performing on-site monitoring visits to assess data accuracy and consistency
- Verifying selected source documents against CRFs
- Reviewing compliance with inclusion/exclusion criteria and regulations
- Identifying deviations, quality gaps, and operational challenges
- Implementation of corrective and preventive actions (CAPA)
Study Close-Out Visits
- Conducting end-of-study close-out visits to confirm completion of activities
- Ensuring all data have been collected, verified, cleaned, and submitted
- Confirming proper archiving of essential documents and SOP adherence
- Reviewing final compliance with sponsor expectations and regulatory obligations
- Supporting sites with Ethics Committee (EC) study-closure notifications
