Clinical Site Management
Ensuring consistent, compliant, and well-coordinated study conduct across all participating sites.
Comprehensive Site Operations Support : Proactive coordination and performance oversight for seamless study execution.
Our Clinical Site Management services support seamless site operations through proactive coordination, regulatory compliance, and continuous performance oversight. We work closely with investigators and site teams to ensure uniform understanding of study requirements, timely execution, data quality, and audit readiness throughout the study lifecycle.
Investigator Onboarding and Training
- Coordination of investigator onboarding and site readiness verification
- Conducting structured training sessions on protocol and data collection
- Ensuring consistent understanding of study processes across all sites
Ethics Committee (EC) Dossier Preparation
- Preparation and compilation of site-specific EC submission dossiers
- Submission of dossiers as per institutional EC requirements
- Tracking EC approvals, queries, amendments, and renewals
- Tracking progress-report submissions and close-out notifications
- Ensuring compliance with NDCT Rules 2019, ICH-GCP, and institutional guidelines
Site Communication and Coordination
- Serving as the central communication point for all participating sites
- Conducting regular coordination meetings and sharing progress updates
- Dissemination of study documents, clarifications, and technical guidance
- Maintaining detailed documentation and audit readiness
Data Management Coordination
- Training site teams on CRF completion and data-entry processes
- Oversight of data-entry completeness, accuracy and timelines
- Periodic data-quality reviews and generation of progress reports
- Identification and resolution of data queries across sites
- Routine data cleaning, quality checks, and validation of key variables
- Coordination of final quality control cycles and database lock
Issue Identification and Resolution
- Continuous monitoring to identify operational challenges
- Coordination with site teams and investigators to resolve issues promptly
- Implementing and follow-up CAPA measures, where required
Grant Management and Disbursement
- Verification of site performance milestones
- Processing of site invoices with applicable TDS/GST compliance
- Coordination of timely and transparent site payment disbursement
Ongoing Site Performance Monitoring
- Regular tracking of site progress against study timelines
- Identification of underperforming sites and initiation of corrective actions
- Preparation of periodic progress summaries
Site Close-Out
- Ensuring completion of site close-out activities across all the participating sites
Documentation and Archival
- Maintenance of up-to-date TMF/SMF
- Archival of study documents across all participating sites (typically retained for five years)
