Clinical Site Management · India
GCP-Compliant Site Management for Sponsors Running Trials in India
Shen Clinical Services provides end-to-end clinical site management in India: feasibility, investigator and site selection, ethics committee coordination, patient recruitment, risk-based monitoring with source data verification, and close-out. We reduce sponsor risk through documented site qualification, CRA oversight and inspection-ready investigator site files aligned with ICH-GCP and NDCT Rules 2019.
NDCT Rules 2019CDSCO timelines built into every site plan
ICH E6(R3) GCPRisk-based quality management and monitoring
CTRI RegistrationProspective registration managed for every study
ICMR GuidelinesEthical conduct and informed consent standards
The Sponsor Challenge
Where Trials in India Lose Time, and How We Prevent It
| Sponsor friction point | What typically goes wrong | How Shen Clinical Services handles it |
|---|---|---|
| Delayed site activation | Ethics committee meetings run on fixed calendars, and budget or contract negotiation is done one step at a time. Sites are often selected before anyone confirms the patient pool exists. | We run ethics committee submissions, CTRI registration and site contract negotiation in parallel, not one after another. We only select sites with a registered ethics committee and a confirmed meeting schedule, and an activation tracker with set milestones goes to the sponsor every week. |
| Recruitment shortfalls and drop-outs | Feasibility answers are optimistic estimates rather than actual patient counts. Once enrolled, patients drop out because of travel burden and missed visit windows. | We verify patient pools against site records and past enrolment performance before committing a site. Retention measures include visit reminders in local languages, travel reimbursement within ethics-committee-approved limits, and a named coordinator for each patient cohort. |
| Data queries and transcription errors | Source documents don’t match what’s entered in the electronic data capture (EDC) system, and query backlogs build up before database lock. | We monitor on a risk basis (ICH E6(R3)), targeting source data verification at the data points that matter most. Coordinators are trained before the first patient enters, and query turnaround is tracked against an agreed target for each site. |
Our Process
Our Clinical Site Management Process
Four phases, one accountable team, from the first feasibility call to an inspection-ready close-out.
PHASE 01
Site Feasibility, Investigator Selection and Ethics Committee Coordination
We run each clinical trial feasibility study against real site data: patient counts drawn from the site’s own records, past recruitment performance, how the investigator performed in earlier studies, and the ethics committee’s meeting cycle. Only qualified sites, with registered ethics committees and suitable infrastructure, go on the shortlist. We then coordinate ethics committee submissions, CTRI registration and site agreements in parallel to shorten the time to activation.
PHASE 02
Accelerated Patient Recruitment and Retention
Our patient recruitment strategies for clinical trials start from the protocol’s eligibility criteria and work back to where those patients are actually seen: specialist clinics, referral networks and site databases. We support informed consent in the participant’s language, including audio-video recording of consent where the NDCT Rules require it, and track screen-failure and drop-out rates for each site every week.
PHASE 03
Clinical Site Monitoring and Source Data Verification (SDV)
As a site monitoring CRO in India, we deliver GCP-compliant site monitoring under a risk-based monitoring plan. That plan combines on-site visits, remote and central monitoring, and targeted SDV. Our clinical research associates (CRAs) check consent documentation, safety reporting timelines, accountability for the investigational product, and that the protocol is being followed, then escalate any deviation with a documented corrective and preventive action (CAPA).
PHASE 04
Site Close-out and Regulatory Inspection Readiness
Close-out includes reconciling the investigational product and arranging its return or destruction, completing the investigator site file, notifying the ethics committee, and updating the trial’s CTRI status. We prepare sites for inspection by CDSCO or other regulators through mock audits and document checks, and confirm records are archived for 5 years after study completion, or 2 years after the drug batch’s expiry date, whichever is later.
Regulatory Compliance
Proven Compliance With India’s Clinical Trial Rules
Every site we manage works to the timelines set by CDSCO under the New Drugs and Clinical Trials (NDCT) Rules, 2019. We build these deadlines into each site’s monitoring plan.
| Regulatory requirement | Timeline set by the rules | How we enforce it at site level |
|---|---|---|
| Clinical trial application review | 30 working days for domestic trials; 90 working days for global trials | Submission documents prepared alongside site selection, so sites are ready to activate on approval |
| Ethics committee registration | 45 working days | Only sites with ethics committees already registered with CDSCO are shortlisted |
| Serious adverse event (SAE): initial report | Within 24 hours of the event | Site staff trained in SAE reporting before activation; CRA confirms the report within the window |
| SAE: analysed follow-up report | Within 14 days | CRA tracks every open SAE against this deadline |
| Ethics committee SAE and compensation recommendation | Within 30 days of receiving the report | Ethics committee communications tracked in the monitoring log |
| Compensation payment after a regulator’s order | Within 30 days of the order | Sponsor notified on the day the order arrives |
| Trial record retention | 5 years after study completion, or 2 years after the drug batch’s expiry date, whichever is later | Archiving checked as part of close-out, with document storage verified |
Standards every site follows: NDCT Rules 2019 (as amended), ICH E6(R3) Good Clinical Practice, mandatory CTRI registration, and the ICMR National Ethical Guidelines.
Resource Spotlight
Planning a trial in India for the first time? See our regulatory guidance and compliance services for support with CDSCO approval, CTRI registration and ethics committee requirements. Our medical writing services prepare the protocol, informed consent forms and ethics committee documents. For full-service support, see our clinical trial services in India.
Need Sites That Recruit on Schedule?
For trials in planning: get a site feasibility assessment with verified patient pools, investigator track records and a written activation timeline.
For trials that are behind: our site rescue team reviews under-performing sites, identifies replacement sites and works on recovering your recruitment timeline.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098