Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Clinical Research Organization India | Phase II–IV Trials | Integrated Analytical Testing | Auriga Research

Backed by the Arbro Group's 40+ years of analytical heritage — Auriga Research has been a CDSCO-approved CRO since 2007. We provide end-to-end contract research services spanning Phase II through Phase IV clinical trials, pharmacovigilance, biostatistics, site management, real world evidence, medical writing, and BA/BE study monitoring with PK analysis.

Clinical studies are conducted through our network of 370 investigator sites and 100+ SMO partners across India — managed by Auriga's experienced clinical operations team. Every trial is supported by our own NABL- and USFDA-inspected bioanalytical laboratories — one chain of custody, one QMS, one accountability.

Request a CRO Proposal Call +91-7428116100
12,000+

Clients served across Arbro Group services

1,000+

Scientists, monitors, and technical staff

370

Investigator sites across India

100+

SMO collaborations · 5-region coverage

Why Auriga

Most CROs outsource their bioanalytical work. Auriga does not. Every clinical trial is supported by our own NABL- and USFDA-inspected analytical laboratories — one chain of custody, one QMS, one accountability. CDSCO-approved CRO since 2000, backed by the Arbro Group's unbroken analytical accreditation since 2003.

Regulated Clinical Trials

Full-spectrum CRO services for pharmaceutical and biotech sponsors — protocol design and regulatory strategy through clinical execution, biostatistics, pharmacovigilance, and final regulatory submission.

Phase II–IV Clinical Trials

Multi-centre Phase II dose-finding, Phase III pivotal efficacy, and Phase IV post-marketing studies — protocol design through clinical study report per ICH E3.

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Pharmacovigilance

PSMF, PSUR/PBRER, signal detection, and full-service QPPV outsourcing aligned with CDSCO and ICH E2 guidelines.

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Site Management

Site identification, investigator selection, initiation, patient recruitment, and monitoring across our 370-site investigator network and 100+ SMO partners.

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Biostatistics & Data Management

Statistical analysis plans, randomisation, CDISC-compliant data management, interim analyses, and sample size calculations for regulatory submissions.

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Real World Evidence

Observational studies, registry design, retrospective database analyses, and RWE study reports for HTA and payer submissions.

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Medical Writing & Regulatory Submissions

CTD-format dossier preparation, clinical study reports, IBs, protocols, ICFs, and submission packages for CDSCO, FDA, and EMA.

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BA/BE Study Monitoring & PK Analysis

Independent CRO monitoring of bioequivalence studies with PK analysis by Phoenix WinNonLin. Auriga provides monitoring and PK analysis only — we do not conduct BE studies.

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Clinical Research & Claims Studies

Human clinical studies that substantiate marketing claims and regulatory submissions for consumer health categories — cosmetics, nutraceuticals, and Ayurveda.

Cosmetics & Personal Care Studies

HRIPT, SPF claim substantiation (ISO 24444), dermal tolerance, anti-ageing, moisturisation, and brightening efficacy studies. 105+ cosmetic clinical studies completed across 530+ products.

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Nutraceutical Clinical Studies

Efficacy and safety studies for dietary supplements and functional foods — bioavailability, dose-response, and consumer acceptance trials supporting FSSAI nutraceutical claims.

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Ayurveda & Herbal Studies

AYUSH Ministry-aligned clinical research for classical and proprietary Ayurvedic formulations — safety, efficacy, and traditional knowledge documentation.

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Cosmetics Clinical Research — Proof Points

  • ✓ 105+ cosmetic clinical studies completed
  • ✓ 530+ products tested across categories
  • ✓ Group clientele includes Mamaearth, L'Oréal, Mankind, and Piramal Healthcare

Note: clients listed are associated with the Arbro Group across services (testing, manufacturing, and clinical research). They are not exclusively Auriga clinical-study clients.

Technology Advantage

Every trial managed on Auriga's integrated digital platform — built for sponsor visibility, regulatory inspection readiness, and remote monitoring.

OneClinicalTrials (CTMS)

Clinical trial management system — milestones, site status, subject tracking, and sponsor dashboards in real time.

Clinevo EDC / eCRF

Electronic data capture with MedDRA coding, edit checks, and CDISC-aligned data exports.

eTMF · eISF · rSDV

Electronic trial master file, investigator site file, and remote source data verification — full inspection-ready evidence trail.

OnePharmacovigilance · OneQMS

Safety case management, ICSR processing, and quality management system across all clinical and analytical operations.

All systems hosted on AWS · Compliant with 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR.

Pan-India Investigator Network

Clinical studies conducted through our network of investigator sites and SMO collaborations — managed end-to-end by Auriga's clinical operations team.

370

Investigator sites across India

100+

SMO collaborations

5

Regions: N · S · E · W · Central

In-house

Site management & monitoring team

Accreditations & Regulatory Standing

Continuous regulatory standing across India's apex bodies — backing every clinical and analytical deliverable.

DCGI

Since 1995

CDSCO-approved CRO

Since 2000

NABL Central Lab

ISO/IEC 17025

CAP Support

Central lab capability

How We Work

A structured approach from feasibility assessment to final regulatory submission — designed to keep your study on timeline and budget.

01

Feasibility & Proposal

We assess your study requirements, therapeutic area, regulatory pathway, and timeline. You receive a detailed proposal with cost breakdown and milestones within 5 business days.

02

Regulatory & Ethics

Our regulatory team prepares CDSCO submissions, Ethics Committee applications, CTRI registration, and all required approvals before first patient enrolment.

03

Trial Execution

Site initiation across our 370-site network, patient recruitment, EDC data capture, monitoring (rSDV), and bioanalytical sample analysis — all on Auriga’s integrated digital platform.

04

Reporting & Submission

Clinical study reports per ICH E3, statistical analyses, regulatory dossier compilation, and submission support for CDSCO, FDA, or EMA pathways.

Related Services

Auriga's CRO capabilities are complemented by our in-house testing laboratories and CDMO division — providing an integrated development pathway from formulation to market.

Pharmaceutical Testing Analytical, stability, microbiology Cosmetics Testing Lab Safety, efficacy, regulatory compliance CDMO Services Contract manufacturing & formulation Nutraceutical Testing FSSAI, AYUSH, stability testing Medical Device Testing Biocompatibility, safety, performance Phase II–IV Clinical Trials CDSCO regulated · 370 sites · Bioanalytical

Frequently Asked Questions

What is a Clinical Research Organization (CRO)?
A Clinical Research Organization (CRO) is a company that provides outsourced research services to pharmaceutical, biotechnology, and medical device companies. CROs manage clinical trials, bioanalytical testing, pharmacovigilance, regulatory submissions, and data management on behalf of sponsors. Auriga Research operates as a CDSCO-approved CRO in India, handling Phase II through Phase IV clinical trials with full regulatory compliance.
Is Auriga Research approved by CDSCO for clinical trials?
Yes. Auriga Research has been a CDSCO-approved CRO since 2000 and the Arbro Group has held unbroken analytical accreditation since 2003. Our clinical research operations comply with the New Drugs and Clinical Trials Rules 2019 and ICH-GCP E6(R3) — the current Good Clinical Practice guideline, effective May 2025 and superseding E6(R2).
Does Auriga conduct bioequivalence (BE) studies?
No. Auriga Research does not conduct BE studies. We provide independent CRO monitoring of bioequivalence studies and pharmacokinetic analysis using Phoenix WinNonLin. Sponsors engage our team for protocol review, on-site monitoring of clinical and bioanalytical phases at partner units, and independent PK analysis and reporting.
Where are Auriga’s clinical trial sites located?
Clinical studies are conducted through Auriga’s network of 370 investigator sites and 100+ SMO collaborations across India — covering North, South, East, West, and Central India. Site selection, initiation, and monitoring are managed by Auriga’s in-house clinical operations team.
What digital systems does Auriga use for clinical trials?
Every trial runs on Auriga’s integrated digital platform: OneClinicalTrials (CTMS), Clinevo EDC/eCRF with MedDRA coding, eTMF/eISF/rSDV for remote source data verification, and OnePharmacovigilance for safety. All systems are hosted on AWS and compliant with 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR.
How does Auriga differ from Lambda, Veeda, and other Indian CROs?
Most CROs outsource their bioanalytical work. Auriga does not. Every clinical trial is supported by our own NABL and USFDA-inspected analytical laboratories — one chain of custody, one QMS, one accountability. This integrated model reduces sponsor coordination, shortens timelines, and removes the data-transfer risk inherent in multi-vendor trial models.

Start Your Clinical Research Project

CDSCO-approved CRO since 2000 with 370 investigator sites, integrated NABL + USFDA bioanalytical labs, and full digital platform (OneClinicalTrials, Clinevo EDC, OnePharmacovigilance). Get a detailed proposal within 5 business days.

+91-7428116100 Request a CRO Proposal

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