Clinical trials

With years of dedicated research experience, we offer a comprehensive range of clinical services.

Our clinical trial services range from pilot studies, proof of concept studies to large multicentric clinical studies for evaluating efficacy and safety in humans.

We offer customized study designs to validate all product-related health and marketing claims. We offer end-to-end service from protocol design to manuscript publishing. We conduct clinical trials in nutraceuticals, herbal, dietary supplements, nutraceutical ingredients, and ayurveda products for domestic as well as overseas clients.

We conduct clinical trials in a wide range of indications like joint health, bone health, metabolic health, optimum nutrition, lifestyle disorders, reproductive health, oral health, beauty and wellness, pediatric healthcare, etc.

Steps in Conducting Clinical Trials

Briefing from the sponsor regarding trial requirements
Development of synopsis and clinical trial budget
Sponsor agreements and Clinical Trial Agreements (CTA)
Shortlists Study Sites from the database
Site feasibility visit (Investigator discussion of the Study Synopsis, enrollment strategy, Patient Pool, Referral Activities, and other Logistics)
Collate and Compile site responses into a Site Feasibility Grid
Grade and prioritize selected sites
Including study specific Projections, Timelines, and Risk Evaluation and Mitigation Strategy
Keeping the client updated and taking consent
Completion of essential documents/dossier for submission to the EC and Regulatory (if applicable)
EC and Regulatory (if applicable) Submission and Seeking Permission
CTRI and other Portal Registration
Site initiation visit
Enrolments and Follow-Ups (Data Entry with QC/QA)
Trial monitoring and audits
Regular Client Updates
Communications with the ECs, Regulatory, Investigator and Client
Clinical data management and statistical analysis
Clinical Study Report (Interim reports if applicable)
Manuscript/White paper and communication to scientific journals

Clinical trial success hinges on selecting a dependable CRO strategically. Our seasoned professionals, offering a diverse portfolio of clinical research services, coupled with a robust Quality Management System fostered by a strong quality culture, position us as the preferred partner for top Nutraceutical firms globally.