Clinical Trial Management
Full-service project management for Phase I–IV studies — one accountable team from protocol to clinical study report.
- Study plans, timelines and risk management
- Vendor and site coordination
- Budget and payment management
Our Services
End-to-end clinical research services — from feasibility and start-up to close-out and reporting.
Site Management (SMO)
Research-ready sites with experienced investigators and dedicated, GCP-trained coordinators — managed to one quality standard.
- Experienced PIs and sub-investigators
- Dedicated clinical research coordinators
- Standardised SOPs across sites
Feasibility & Site Selection
Evidence-based feasibility in 5–7 business days so you choose sites that will actually recruit.
- Protocol and eligibility criteria review
- Patient-pool and competing-study analysis
- Investigator interest and experience assessment
Patient Recruitment & Retention
Ethical, targeted recruitment strategies and participant support programs that keep enrollment on plan.
- Study-specific recruitment plans
- Pre-screening and referral networks
- Ethics-approved awareness materials
Regulatory & Ethics Services
CDSCO, CTRI and ethics committee submissions handled by specialists who know the process inside out.
- Clinical trial applications to CDSCO
- CTRI registration and updates
- Ethics committee submissions and renewals
Clinical Monitoring & Quality Assurance
Risk-based monitoring and independent quality assurance that keep your data inspection-ready.
- Site initiation, monitoring and close-out visits
- Risk-based and centralised monitoring
- Source data verification and review
Data Management & Biostatistics
Clean, analysis-ready data through validated systems, rigorous cleaning and expert statistical support.
- eCRF design and edit checks
- Data management plans
- Query management and data cleaning
Pharmacovigilance & Medical Writing
Safety reporting that meets regulatory timelines, and clear, compliant scientific documents.
- SAE reporting and follow-up
- Safety database reconciliation
- Periodic safety reports
How we work
One accountable team, five clear stages
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01
Feasibility & site selection
Protocol review, patient-pool analysis and investigator interviews to identify sites that can genuinely deliver.
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02
Start-up & approvals
Ethics committee, CDSCO and CTRI submissions, site contracts, budgets and site initiation visits.
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03
Recruitment & enrollment
Targeted, ethical recruitment plans with pre-screening, consent support and retention programs.
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04
Conduct & monitoring
Risk-based monitoring, source data verification, safety reporting and real-time progress dashboards.
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05
Close-out & reporting
Database lock support, site close-out, archiving and inspection readiness.
Ready to start your next study in India?
Share your protocol synopsis and we will return a site feasibility assessment and start-up plan — confidentially and within five business days.
- Confidential review under NDA
- Response within one business day
- Direct PI and site assessment