We have extensive knowledge of local regulations, GCPs, and can efficiently use diverse modern study management tools and modern data capture/transmission systems. Our SOPs and quality steps ensures regulatory compliance at every task we undertake in clinical monitoring and we believe that we are positioned to become your partner of choice in effective and efficient management of investigator sites.
Our Clinical monitoring services includes but not limited to
- Conduct of feasibility study
- Site identification and Site Initiation,
- Pre study visits,
- Routine monitoring,
- Review, collection and processing of regulatory documents
- Source data verification (SDV)
- Unblinded/unblinded pharmacy monitoring visits
- Co-monitoring,
- Close out visits
- Site trainings
- Corrective and preventive actions
- Communication with sites
- Data Query Resolution
- Oversight in subject recruitment and strategic guidance
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