Slow study start-up
Feasibility and site activation often drag on for months. We return data-backed feasibility in 5–7 business days and run ethics and regulatory submissions in parallel.
For Sponsors & CROs
A dependable execution partner for Phase I–IV studies, medical device investigations and real-world evidence in India.
Why India, why Ethica
Local execution expertise for global-quality studies
Running a clinical study in India offers access to large, treatment-naive patient populations, experienced investigators and cost-efficient operations — but only when execution is managed by people who know the system from the inside.
Ethica Research gives sponsors and CROs one accountable partner for feasibility, site selection, regulatory approvals, patient recruitment, site management, monitoring and data. Whether you need a full-service CRO or a reliable site network to complement your own team, we adapt to your operating model.
Phase I–IVClinical study support
ICH-GCPAligned SOPs & training
12Therapeutic areas covered
1 dayResponse to every enquiry
Problems we solve
Built around the issues that delay studies
Recruitment shortfalls
Most delayed trials miss enrollment targets. We build recruitment plans around patient registries, physician referral networks and ethics-approved community outreach from day one.
Regulatory complexity
CDSCO, CTRI and ethics committee requirements change often. Our regulatory specialists manage every submission and query end-to-end.
Limited visibility
Sponsors deserve to know where their study stands. Weekly dashboards track enrollment, data entry, open queries and deviations — no surprises.
Capabilities
Full-service or exactly what you need
Clinical Trial Management
Full-service project management for Phase I–IV studies — one accountable team from protocol to clinical study…
Site Management (SMO)
Research-ready sites with experienced investigators and dedicated, GCP-trained coordinators — managed to one…
Feasibility & Site Selection
Evidence-based feasibility in 5–7 business days so you choose sites that will actually recruit.
Patient Recruitment & Retention
Ethical, targeted recruitment strategies and participant support programs that keep enrollment on plan.
Regulatory & Ethics Services
CDSCO, CTRI and ethics committee submissions handled by specialists who know the process inside out.
Clinical Monitoring & Quality Assurance
Risk-based monitoring and independent quality assurance that keep your data inspection-ready.
Data Management & Biostatistics
Clean, analysis-ready data through validated systems, rigorous cleaning and expert statistical support.
Pharmacovigilance & Medical Writing
Safety reporting that meets regulatory timelines, and clear, compliant scientific documents.
Operating principles
How we work with sponsors
Ethics before everything
Participant safety, valid informed consent and data integrity are never traded for speed. Our processes are built around them.
Investigator-led quality
Experienced principal investigators and GCP-certified coordinators run every site, supported by an independent QA function.
Rapid, transparent start-up
Parallel submissions, pre-negotiated site agreements and standard budgets help studies go live sooner.
Partnership, not outsourcing
We co-own timelines with you, escalate early and stay accountable from first contact to final report.
Start the conversation
Request a confidential feasibility assessment
Tell us about your study. A senior member of our clinical operations team will review it and respond within one business day.
- Confidential review under NDA
- Response within one business day
- Direct PI and site assessment
Sponsor FAQs
How quickly can you deliver feasibility?
We usually deliver a site-by-site feasibility assessment with realistic enrollment projections within five to seven business days of receiving a protocol synopsis under NDA.
Do you support medical device investigations?
Yes. We support pilot, pivotal and post-market clinical investigations of medical devices and in-vitro diagnostics in line with the Medical Devices Rules, 2017.
Can you work with overseas sponsors and CROs?
Absolutely. We regularly act as the local execution partner for international sponsors and CROs, supporting regulatory submissions, site management and monitoring in India.
What does your quality system look like?
We operate under a documented quality management system with SOPs, training records, internal audits, CAPA management and regular mock inspections at sites.