Clinical research organisation · India
Your clinical research partner in India.
ACRS helps pharmaceutical, nutraceutical and cosmetic sponsors run compliant, on-time studies in India, from regulatory approval and site start-up to monitoring, data and the final report.
Why ACRS
The local expertise of an Indian CRO, with the discipline global sponsors expect
Local regulatory know-how
CDSCO applications, ethics committee approvals and CTRI registration handled by a team that works with them every week.
Sites ready to enrol
A network of 100+ trial sites and 300+ investigators, supported by our own trained study coordinators.
Built for overseas sponsors
One accountable project manager, clear reporting and a single point of contact across sites, vendors and regulators.
Quality first
ICH-GCP conduct, ALCOA source documentation and a 21 CFR Part 11 compliant data system as standard.
Services
Full service, or just the functions you need
Our specialisation
Clinical evidence for nutraceutical, herbal and cosmetic products
Regulators, retailers and consumers increasingly expect supplement, Ayurvedic and cosmetic brands to back their claims with clinical data. ACRS designs and runs these studies to the same GCP standard as a drug trial, combining India's experience with traditional medicine and cost-effective patient access.
- Nutraceuticals & supplements
- Ayurvedic & herbal medicines
- Cosmetics & cosmeceuticals
- Claim substantiation studies
How a study runs with ACRS
From feasibility to final report
- 01
Feasibility
Site and patient feasibility, investigator selection and a realistic enrolment plan.
- 02
Approvals
CDSCO and ethics committee submissions, CTRI registration and contracts.
- 03
Start-up
Site initiation, CRC placement, TMF set-up and investigational product logistics.
- 04
Conduct
Recruitment, risk-based monitoring, safety reporting and ongoing QA.
- 05
Close-out
Data cleaning, database lock, statistics and the clinical study report.
Therapeutic expertise
Experience across 15 therapeutic areas
Trials for new drugs and medical devices, with an investigator database covering nearly every major therapeutic area.
- Oncology
- Cardiovascular
- Central Nervous System
- Endocrinology & Metabolic
- Nephrology
- Respiratory
- Immunology
- Dermatology
- Ophthalmology
- Orthopedics
- Gynecology
- Ear, Nose & Throat
- Ayurveda & Herbal Medicine
- Nutraceuticals
- Cosmetics & Cosmeceuticals
Case studies
Track record, shared under NDA
Most sponsor work is confidential. We are happy to share relevant study summaries, including phase, indication, enrolment and timelines, once an NDA is in place.
Ask for case studies under NDA →Leadership
The people accountable for your study
Dr. Abhijit MunshiFounder & Director
Dr. Shailesh MalekarProject Development
Shraddha GhaiBusiness Development
Gaurav TanksaleRegulatory Affairs
Can overseas sponsors run clinical trials in India through ACRS?
Yes. ACRS acts as your local partner in India, handling regulatory approvals, site selection and management, monitoring, data management and reporting, while you keep a single point of contact.
What approvals are needed to run a clinical trial in India?
Trials of new drugs need permission from the Central Drugs Standard Control Organisation (CDSCO) under the New Drugs and Clinical Trials Rules, 2019, approval from a registered ethics committee at each site, and registration on the Clinical Trials Registry – India (CTRI) before the first patient is enrolled.
Do you work alongside global CROs?
Yes. Besides full-service studies, we work as a functional service provider for monitoring, site management, regulatory or data management, complementing a sponsor or CRO team.
Do you run nutraceutical, Ayurvedic and cosmetic studies?
Yes. Nutraceutical, herbal and cosmeceutical trials are a specialisation of ACRS, alongside conventional drug and medical device studies.
Planning a study in India?
Share your protocol synopsis, target enrolment and timelines. We will come back with feasibility, approach and a budget.