Faster site start-up
Parallel handling of feasibility, contracts, ethics committee dossiers and initiation readiness, tracked against an agreed start-up plan.
Clinical Site Management Organisation · India
Ready sites. Recruited patients. Inspection-ready data.
TrialSite Partners sets up and runs clinical trial sites across India for sponsors and CROs, and takes the coordination load off investigators so they can focus on patients. Pharmacist-led, and built around ICH-GCP and the New Drugs and Clinical Trials Rules, 2019.
ICH-GCP E6(R3) alignedCDSCO NDCT Rules 2019DPDP Act 2023 controls
ICH-GCP E6(R3) principlesNDCT Rules 2019 site conductDPDP Act 2023 privacy controlsPharmacist-led IP oversight
Why sponsors and CROs work with an SMO
India has the patients and the investigators. Sites need the bandwidth.
Busy hospital departments often lack dedicated research staff. Start-up drags, enrolment stalls and queries pile up. We close that gap with people, process and documentation that hold up to monitoring and inspection.
Predictable enrolment
Site-specific recruitment plans built from real patient-flow review, pre-screening logs and retention follow-up for every randomised participant.
Quality you can audit
SOP-driven conduct, ALCOA+ source documentation and timely EDC entry, so your monitors spend visits verifying, not reconstructing.
Services
End-to-end site support, from feasibility to close-out
Take one service or the full package. Every engagement has a clear scope, named owners and agreed timelines.
Site identification & feasibility
Investigator and site shortlists matched to your protocol and patient population.
Learn more →Ethics & regulatory support
EC dossiers, CTRI registration support and site regulatory files.
Learn more →Recruitment & retention
Screening, consent support and follow-up that keeps participants in.
Learn more →CRC staffing
GCP-trained clinical research coordinators, dedicated or shared.
Learn more →Data entry & queries
Source-to-EDC entry on agreed timelines and fast query closure.
Learn more →IP & pharmacy support
Pharmacist-led receipt, storage, dispensing and accountability.
Learn more →Monitoring visit support
SDV-ready documents and fast action-item closure.
Learn more →Site close-out
Reconciliation, ISF completeness, archiving and EC notifications.
Learn more →Why TrialSite Partners
A pharmacist’s eye on every site
We are led by a Doctor of Pharmacy (PharmD), trained in clinical pharmacy, patient counselling and drug safety.
That background shapes how we run sites: careful handling of investigational product, attention to concomitant medications and adverse events, and plain-language support for participants. We are deliberately focused, building a small network of well-run sites and growing it study by study.
Pharmacy-grade IP control
Built to prevent excursions and accountability gaps.
One accountable lead
A single contact for your study across sites.
Visibility for sponsors
Know where every site stands, every week
Each site has a named lead who sends a weekly status covering start-up milestones, screening and enrolment, open queries and upcoming monitoring visits. Issues are flagged early, with a proposed fix, instead of surfacing at the next visit.
Weekly status
Enrolment, queries and milestones by site.
Singapore liaison
Regional coordination for APAC sponsors and CROs.
How we work
A clear path from protocol to first patient in
Four stages, one accountable team, and documentation that is ready for inspection at every step.
- 01Before award
Feasibility
We review your synopsis, map candidate investigators and return a feasibility report with realistic enrolment estimates.
- 02Start-up
Site activation
CDA and CTA support, EC submissions, site staff training and readiness for the site initiation visit.
- 03Conduct
Study delivery
Coordinators on site for recruitment, visits, data entry, IP management and monitoring support.
- 04Completion
Close-out
Final reconciliation, query closure, archiving and EC notifications, with a clean handover.
Partners
Investigator and hospital partners
Partner names will appear here once agreements are in place.
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Start a conversation
Planning a study in India?
Share your protocol synopsis and target indication. We will come back with a site feasibility view within five working days.