The Clinical Research Division of Arbro Group
Clinical Research at Auriga Research conducts ethical, data-driven studies across pharmaceuticals, cosmetics, nutraceuticals, Ayurveda, and food — delivering reliable evidence that supports regulatory approvals and market claims.
Our end-to-end clinical research capabilities span trial management, pharmacovigilance, medical writing, data management, biostatistics, regulatory submissions, and claim substantiation. We operate in full compliance with ICH-GCP, BIS, and Schedule Y guidelines.
We also offer non-regulatory claim substantiation studies for cosmetics and food products. Our labs are USFDA-inspected, NABL-accredited, and WHO-prequalified.
Focus Areas
Ethical Excellence
Every clinical study is conducted with the highest ethical standards, adhering to ICH-GCP guidelines, BIS standards, and Schedule Y requirements.
Data Integrity
Robust clinical data management and biostatistics ensure integrity, traceability, and regulatory-grade quality across all study endpoints.
Timely Delivery
Efficient trial management and streamlined workflows ensure on-time delivery of study milestones without compromising scientific rigor.
Core Offering
Pharmacovigilance & Drug Safety
Comprehensive pharmacovigilance systems including adverse event reporting, signal detection, risk management, and post-marketing safety surveillance.
Clinical Data Management & Biostatistics
Robust data management systems and expert biostatistical analysis ensuring data integrity, quality, and regulatory compliance across all study phases.
Regulatory Submissions
Expert preparation and filing of regulatory dossiers, CTDs, and submissions for CDSCO, USFDA, and global regulatory authorities.
Quality Assurance & Compliance Audits
Systematic quality assurance programs and compliance audits ensuring all clinical operations meet ICH-GCP, regulatory, and sponsor requirements.
Multicentric Clinical Trial Execution
End-to-end management of multicentric clinical trials across multiple sites, ensuring protocol compliance, patient safety, and data consistency.
Medical Writing & Documentation
Expert medical writing services including clinical study reports, investigator brochures, protocols, informed consent forms, and regulatory documents.
Clinical Trial Phases We Support
Phase I
First-in-human studies evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers.
Phase II
Exploratory efficacy trials to assess therapeutic effectiveness, optimal dosage, and side effects in target patient populations.
Phase III
Confirmatory multicentric trials providing definitive evidence of efficacy and safety for regulatory submissions.
Phase IV
Post-marketing surveillance studies monitoring long-term safety, effectiveness, and real-world drug performance.
Clinical Research Across Domains
Our clinical research expertise extends beyond pharmaceuticals to cover multiple domains requiring evidence-based validation.
- Pharmaceuticals — Regulatory clinical trials (Phase I–IV), BA/BE studies
- Cosmetics & Personal Care — Claim substantiation, dermatological studies
- Nutraceuticals — Efficacy and safety studies for health supplements
- Ayurveda & Herbal — Clinical validation of traditional formulations
- Food & Functional Foods — Health claim substantiation studies
Accreditations & Certifications
Our clinical research division operates under strict regulatory oversight with full compliance to ICH-GCP guidelines, BIS standards, and Schedule Y requirements — ensuring every study meets international quality benchmarks.
Request a Clinical Research Consultation
Share your clinical research requirements and our team will get back to you within 24 hours with a detailed proposal.
Partner With Us for Clinical Excellence
USFDA-inspected, NABL-accredited, and WHO-prequalified — our clinical research team delivers the evidence you need.
Request a Consultation