Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Phase II–IV Clinical Trials India | CDSCO CRO | Auriga Research

Auriga Research is a CDSCO-approved CRO since 2000 with DCGI approval since 1995, delivering regulated Phase II–IV clinical trials across India. Studies are executed through our network of 370 investigator sites and 100+ SMO partnerships spanning North, South, East, West, and Central India — managed by our clinical operations team from Gurugram, Haryana.

All operations follow ICH E6(R3) Good Clinical Practice (effective May 2025) and the New Drugs and Clinical Trials Rules 2019. Every trial is supported by our own NABL- and USFDA-inspected bioanalytical laboratory — bioanalytical samples never leave the Auriga ecosystem. One chain of custody, one QMS, no third-party analytical delays.

For cosmetics and personal care clinical studies — HRIPT, SPF, anti-ageing efficacy — see our Clinical Research and Claims Studies page.

Request a Trial Proposal Call +91-7428116100

Why Auriga — The Integration Differentiator

Auriga is one of the few CROs in India with a NABL- and USFDA-inspected analytical laboratory under the same management. Bioanalytical samples do not leave the Auriga ecosystem — one chain of custody, one QMS, no third-party analytical delays. Most CROs outsource bioanalytical work to vendor labs; we do not. The result: shorter timelines, fewer data-transfer reconciliations, and a single line of accountability from PK sample collection to final CSR.

370

Investigator sites

100+

SMO partnerships

DCGI 1995

CDSCO since 2000

NABL + USFDA

Integrated analytical lab

Documented Study Experience

A sample of clinical studies Auriga has managed across therapeutic areas. Full study lists, role definitions, and references are available under NDA during the proposal stage.

Oncology

Study	Design	Subjects	Sites
Netupitant + Palonosetron (CINV)	Post-Marketing Observational	700	14
Breast Cancer IIS	Investigator-Initiated Study	2,500	—

Endocrinology / Metabolic

Study	Design	Subjects	Sites
Remogliflozin (Type 2 Diabetes)	Real World Study	5,000	100

Dermatology

Study	Design	Subjects	Sites
Bilastine	Post-Marketing Observational	1,000	250
Glabrous Tinea	Real World Study	1,500	300

Cardiology

Study	Design	Subjects	Sites
Vanoxerine	Phase II	78	3

Vaccine

Study	Design	Subjects	Sites
H1N1 Vaccine	Phase II / III	360	4
Pseudomonas aeruginosa Vaccine	Phase III	210	5

Medical Device

Study	Design	Subjects	Sites
Hemolung	Phase I	—	—
VELVERT	Post-Marketing Surveillance	—	—

Service Capabilities

Phase II Studies

✓ Dose-finding and dose-response designs
✓ Proof-of-concept studies
✓ Therapeutic exploratory trials
✓ Adaptive Phase II/III designs

Phase III Pivotal Trials

✓ Multi-centre confirmatory efficacy trials
✓ Active-comparator and placebo-controlled designs
✓ Non-inferiority and superiority designs
✓ Long-term safety extensions

Phase IV / PMS

✓ Post-marketing surveillance studies
✓ Real World Studies (RWS) and registries
✓ Comparative effectiveness research
✓ Investigator-initiated studies (IIS)

BA/BE Monitoring & PK Analysis

✓ Independent CRO monitoring of BE studies
✓ Protocol and SAP design review
✓ PK analysis with Phoenix WinNonLin
✓ Auriga does not conduct BE studies — conduct is at the sponsor\'s designated BE site

Technology Platform

Every trial runs on Auriga's integrated digital platform — built for sponsor visibility, regulatory inspection readiness, and remote monitoring under ICH E6(R3).

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, IWRS randomisation, 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

Safety case management, ICSR processing, MedDRA coding, and CDSCO Sugam SAE/SUSAR reporting.

All systems compliant with 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR.

Trial Execution Process

Eight stages from regulatory application through final clinical study report — designed for CDSCO inspection readiness and sponsor visibility at every step.

Regulatory Application — Sugam Portal

Clinical Trial Application (CTA) and Form CT-04 / CT-06 filings on the CDSCO Sugam portal with full IMPD, IB, and protocol package.

SEC / IEC Dossier Preparation

Subject Expert Committee dossier compilation and Independent Ethics Committee submission packages — protocol, ICF, IB, GCP certificates, and investigator credentials.

CTRI Registration

Clinical Trials Registry – India (CTRI) prospective registration before first patient enrolment, mandated under New Drugs and Clinical Trials Rules 2019.

Site Initiation & GCP Training

Site qualification visits, investigator and study coordinator GCP training (ICH E6 R3), pharmacy and lab setup, and study-specific procedure rehearsals.

EDC & eTMF Setup

Clinevo EDC build with edit checks and MedDRA coding, eTMF and eISF deployment, randomisation in IWRS, and database go-live UAT.

Monitoring (On-site & Remote)

Risk-based monitoring per ICH E6 R3 — on-site SDV at trigger thresholds, remote SDV through rSDV portal, and centralised statistical monitoring.

SAE Reporting — Sugam

Expedited SAE and SUSAR reporting to CDSCO via Sugam within mandated timelines, IEC communication, and DSUR/PSUR generation.

Data Lock & Clinical Study Report

Database lock, statistical analysis per locked SAP, ICH E3 CSR authoring, regulatory query responses, and submission support for CDSCO / FDA / EMA.

Bioanalytical Laboratory Capabilities

Our NABL- and USFDA-inspected bioanalytical laboratory operates under Good Laboratory Practice principles with validated analytical methods for pharmacokinetic sample analysis. Method development and validation follow FDA Bioanalytical Method Validation Guidance (2018), EMA Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/192217/2009 Rev.1), and ICH M10.

Instrumentation includes multiple triple-quadrupole LC-MS/MS systems, UHPLC platforms, GC-MS, and immunoassay (ELISA) capabilities. We process plasma, serum, whole blood, urine, and tissue homogenate samples with validated extraction procedures (protein precipitation, liquid-liquid extraction, solid-phase extraction). All systems operate under 21 CFR Part 11 compliant data management with full audit trails.

Related Services

CRO Services Overview Full CRO capabilities BA/BE Monitoring & PK Independent monitoring · Phoenix WinNonLin Site Management 370 investigator sites · 100+ SMOs Biostatistics & Data ICH E9(R1) · CDISC · SAS + R Pharmacovigilance Drug safety monitoring · PSUR · PBRER Cosmetics Clinical Studies HRIPT · SPF · Anti-ageing efficacy

Frequently Asked Questions

What phases of clinical trials does Auriga manage?

Auriga Research manages Phase II dose-finding, Phase III pivotal efficacy, and Phase IV post-marketing surveillance studies. We do not run dedicated Phase I units; for first-in-human pharmacokinetic and dose-escalation studies, we provide bioanalytical support, PK analysis (Phoenix WinNonLin), and monitoring oversight to sponsor-selected Phase I sites.

Is Auriga compliant with ICH E6(R3) GCP?

Yes. All clinical trial operations at Auriga follow ICH E6(R3) — the current Good Clinical Practice guideline, effective May 2025 and superseding E6(R2). Monitoring plans, risk-based quality management, electronic records, and investigator oversight processes are aligned with E6(R3) and the CDSCO New Drugs and Clinical Trials Rules 2019.

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. Study conduct is at the sponsor's designated BE site; Auriga manages protocol design review, regulatory application, monitoring, and data analysis.

Where are Auriga's clinical trial sites located?

Clinical trials are executed across our network of 370 investigator sites and 100+ SMO partnerships spanning North, South, East, West, and Central India — managed by our clinical operations team from Gurugram, Haryana. We do not own dedicated clinical pharmacology beds; site selection is study-specific, aligned with therapeutic area, patient population, and sponsor preference.

What digital systems does Auriga use for clinical trials?

Every trial runs on Auriga's integrated digital platform: OneClinicalTrials CTMS for project state, Clinevo EDC/eCRF with MedDRA coding for data capture, eTMF and eISF for trial master file management, rSDV for remote source data verification, and OnePharmacovigilance for safety case management. All systems are 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR compliant.

What bioanalytical methods does Auriga use?

Auriga's NABL- and USFDA-inspected bioanalytical laboratory employs validated LC-MS/MS, HPLC-UV, GC-MS, immunoassays (ELISA), and ligand binding assays. Method validation follows FDA Bioanalytical Method Validation Guidance (2018), EMA guidelines, and ICH M10. Selectivity, calibration curve, accuracy, precision, matrix effect, recovery, and incurred sample reanalysis (ISR) are validated before study sample analysis begins.

What is the integrated CRO + analytical lab advantage?

Auriga is one of the few CROs in India with a NABL- and USFDA-inspected analytical laboratory under the same management. Bioanalytical samples do not leave the Auriga ecosystem — one chain of custody, one QMS, no third-party analytical delays or data-transfer reconciliation. Most CROs outsource bioanalytical work to vendor labs; we do not.

What is the typical timeline for a clinical trial in India?

Phase II studies typically run 12-18 months and Phase III pivotal trials 18-36 months. CDSCO regulatory approval (CTA via Sugam portal) typically takes 8-12 weeks for new drug clinical trial applications. Detailed Gantt charts and milestone timelines are provided during the proposal stage.

Plan Your Phase II–IV Clinical Trial

CDSCO-approved CRO since 2000 · ICH E6(R3) compliant · 370 investigator sites · Integrated NABL + USFDA bioanalytical laboratory · Phoenix WinNonLin PK analysis.

+91-7428116100 Request a Trial Proposal

Get a Tailored Recommendation

Talk to a Testing Expert