SMOs support identification, feasibility assessment, and activation of clinical trial sites, ensuring readiness as per sponsor and regulatory requirements

Evaluation of investigators, infrastructure, patient pool, and past performance to ensure suitability for specific clinical trials.

End-to-end support for Ethics Committee submissions, regulatory documentation, approvals, renewals, and compliance with ICH-GCP and local regulations.

Strategic planning and execution of patient recruitment through database management, outreach programs, screening, and retention strategies to minimize dropouts.

Deployment of trained Clinical Research Coordinators (CRCs) to manage daily trial activities including subject visits, documentation, and protocol adherence.

Maintenance of complete, audit-ready Investigator Site Files with accurate documentation throughout the study lifecycle.

Accurate recording and maintenance of source documents, ensuring data integrity and traceability for monitoring and audits.

Operational support for trial execution including scheduling visits, coordinating lab tests, IMP handling, and managing site logistics.

Assistance during sponsor monitoring visits, audits, and inspections, including query resolution and corrective actions.

Timely reporting of Adverse Events (AE), Serious Adverse Events (SAE), and safety follow-ups in coordination with sponsors and CROs.

Support for EDC data entry, query resolution, and coordination with Clinical Data Management teams for clean and timely data submission.

Assistance in budget negotiation, investigator payments, and financial reconciliation as per trial milestones.

Training of investigators and site staff on protocol, GCP, SOPs, EDC systems, and trial-specific procedures.

Support for study close-out activities including document archiving, final reports, and site deactivation.