Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Real World Evidence Studies India | PMO · PMS · RWS | Auriga CRO

Auriga has completed and is actively running some of India's largest Post-Marketing Obligation (PMO) and Real World Evidence (RWE) studies — including a 5,000-subject, 100-site Active PMS in T2DM and a 4,000-subject, 400-site PMO in pulmonology. Multiple manuscripts are currently in progress for peer-reviewed publication.

PMO studies are now a standard condition of CDSCO drug approval under the New Drugs and Clinical Trials Rules 2019. Auriga's 370-site investigator network and OneClinicalTrials CTMS make large multi-site PMO execution operationally straightforward — we have the sites, the systems, and the experience. Coverage spans Post-Marketing Obligation studies, active and passive PMS, Real World Studies (RWS), observational and cross-sectional designs, patient registries, and database / claims studies for HTA and payer evidence.

Operations run on Clinevo EDC for real-time data capture, OnePharmacovigilance for safety signal detection from real-world data, and rSDV for remote source data verification across distributed sites. All compliant with ICH E6(R3), 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR.

Request an RWE Proposal Call +91-7428116100

Why Auriga for Real World Evidence

For RWE specifically, what matters is site coverage, data quality at scale, and pharmacovigilance integration. Auriga has all three.

370 sites

Site Coverage

National network across 4 zones and 15+ states — large multi-site PMOs (up to 500 sites in our largest study to date) initiated and recruited on sponsor timelines.

Clinevo EDC

Data Quality at Scale

Clinevo EDC with edit checks, MedDRA coding, real-time monitoring dashboards, and rSDV for remote source data verification — quality enforced at every site.

OnePharmacovigilance

PV Integration

Adverse events from RWE studies flow directly into OnePharmacovigilance for signal detection — no third-party PV vendor, one chain of custody, faster signal triage.

Documented RWE Study Experience

A sample of Post-Marketing Obligation, PMS, and Real World Studies Auriga has executed across therapeutic areas. Full study lists, role definitions, and references are available under NDA during the proposal stage. Multiple manuscripts in progress.

Endocrinology / Metabolic

Study Design Subjects Sites
Remogliflozin (Type 2 Diabetes) — Active PMS PMS / Active Surveillance 5,000 100
Comprehensive Diabetes Trends Cross-sectional Observational 2,500 500
Sitagliptin + Metformin PMO (Post-Marketing Obligation) 2,500 500

Dermatology

Study Design Subjects Sites
Bilastine — Series 1 PMO (Post-Marketing Obligation) 1,000 250
Bilastine — Series 2 PMO (Post-Marketing Obligation) 330 110
Glabrous Tinea Real World Study (RWS) 1,500 300
Minoxidil + Finasteride PMO (Post-Marketing Obligation) 300 75
Ozenoxacin Real World Study (RWS) 1,500 150

Respiratory / Pulmonology

Study Design Subjects Sites
Mometasone / Indacaterol PMO (Post-Marketing Obligation) 4,000 400

Neurology / Pain

Study Design Subjects Sites
Gabapentinoid PMO (Post-Marketing Obligation) 2,500 50

Regulatory Context — PMO Under NDCT Rules 2019

Post-Marketing Obligation (PMO) studies are now a standard condition of CDSCO new drug approval under the New Drugs and Clinical Trials Rules 2019. CDSCO routinely imposes one or more PMO studies on new drug approvals to characterise real-world safety, effectiveness, and utilisation in the Indian population. Sponsors must submit a PMO protocol, complete enrolment within the specified timeline, submit periodic safety reports, and file the final study report.

Failure to comply with a PMO commitment can trigger CDSCO action including licence suspension or cancellation. PMO study design, site count, and enrolment targets are negotiated at the time of approval — Auriga supports sponsors at the approval-negotiation stage to ensure PMO commitments are operationally realistic, and then executes the study to deliver on the commitment.

Beyond PMO, sponsors increasingly invest in RWE for label expansion, market access, payer evidence, and HTA submissions. Indian RWE is also accepted by regulators and HTA bodies in select markets where India is part of the comparator data set — opening dual-purpose RWE study design opportunities.

RWE Service Capabilities

From CDSCO PMO commitments through HTA dossier evidence — the full RWE study lifecycle on one integrated platform.

PMO Studies (Post-Marketing Obligation)

Mandatory PMO studies imposed by CDSCO as a condition of drug approval under NDCT Rules 2019. Auriga executes large multi-site PMOs across our 370-site investigator network with full CDSCO submission management.

Post-Marketing Surveillance (PMS)

Active and passive PMS programmes — adverse event capture, periodic safety reports, benefit-risk assessment, and label-change support. Integrated with OnePharmacovigilance for end-to-end safety signal detection.

Real World Studies (RWS)

Prospective real-world effectiveness, safety, and utilisation studies generating evidence from routine clinical practice. Supports label expansion, payer evidence, and HTA submissions.

Observational Studies

Prospective cohort, retrospective chart review, case-control, and cross-sectional designs — all on Clinevo EDC with audit-traceable data capture and ICH E6(R3) risk-based monitoring.

Patient Registries

Disease and product registries, long-term follow-up registries, and pregnancy outcome registries — Clinevo EDC + CTMS support multi-year registry operations with stable governance.

Database Studies & HTA Evidence

Retrospective claims / EMR analysis, burden-of-illness studies, treatment-pattern research, and comparative effectiveness for HTA dossiers and payer submissions.

Related Services

CRO Services Overview Full CRO capabilities Phase II–IV Trials CDSCO CRO · documented experience Site Management 370 investigator sites · 100+ SMOs Pharmacovigilance OnePharmacovigilance · PSUR · PADER Biostatistics & Data ICH E9(R1) · CDISC · SAS + R Medical Writing CSR · Manuscripts · eCTD

Frequently Asked Questions

What is a Post-Marketing Obligation (PMO) study and is it mandatory in India?
A Post-Marketing Obligation (PMO) study is an active post-approval study that CDSCO imposes as a condition of new drug approval. Under the New Drugs and Clinical Trials Rules 2019, PMO studies are routinely mandated for new drug approvals to characterise real-world safety, effectiveness, and utilisation. Sponsors must submit a PMO protocol, complete enrolment within the timeline specified by CDSCO, and submit periodic safety reports and the final study report. Failure to comply can result in licence suspension or cancellation.
What RWE study experience does Auriga have?
Auriga has completed and is actively running some of India's largest PMO and RWE studies — including a 5,000-subject, 100-site active PMS for Remogliflozin (T2DM), a 4,000-subject, 400-site PMO for Mometasone/Indacaterol (pulmonology), a 2,500-subject, 500-site PMO for Sitagliptin+Metformin, a 2,500-subject, 50-site PMO for a gabapentinoid (neurology/pain), and multiple dermatology PMO and RWS programmes (Bilastine, Glabrous Tinea, Minoxidil+Finasteride, Ozenoxacin). Multiple manuscripts are in progress for peer-reviewed publication.
What is the difference between PMO, PMS, and RWS?
PMO (Post-Marketing Obligation) is a CDSCO-mandated post-approval study with regulatory commitments. PMS (Post-Marketing Surveillance) is broader ongoing safety monitoring of marketed products — active PMS uses prospective protocols, passive PMS uses spontaneous reporting and signal detection. RWS (Real World Study) is a prospective evidence-generation study using routine clinical practice data, often for label expansion, payer evidence, or HTA submissions. The three overlap operationally but differ in regulatory driver and primary objective.
How does Auriga execute large multi-site PMO studies operationally?
PMO studies are operationally site-intensive. Auriga's 370-site investigator network spans 4 zones (East, West & Central, North, South) across 15+ states — meaning large multi-site PMOs (up to 500 sites in our largest studies to date) can be initiated, recruited, and closed within sponsor timelines. OneClinicalTrials CTMS drives site qualification, milestone tracking, IP management, and investigator payments; Clinevo EDC captures site data; OnePharmacovigilance handles safety signals; and rSDV reduces on-site monitoring trips for distributed sites.
Can Auriga support HTA submissions and payer evidence generation?
Yes. Auriga's RWE division supports burden-of-illness studies, treatment-pattern research, comparative effectiveness studies, and cost-of-illness analyses to build HTA dossiers and payer-submission evidence. Studies are designed with the receiving HTA framework (NICE, CADTH, PBAC, AHB) in mind, with health-economic and outcomes-research expertise from study design through final report.
How does OnePharmacovigilance integrate with RWE studies?
Adverse events captured during RWE studies feed directly into OnePharmacovigilance for case processing, MedDRA coding, signal detection, and CDSCO / PvPI submissions. The integrated platform means safety data from a PMO or PMS does not require third-party transfer to a PV vendor — one chain of custody, one QMS, faster signal detection. PSUR, PADER, and DSUR are produced on the same platform.
What is the typical timeline for a PMO study in India?
PMO study timelines vary by subject count, site count, and disease area. Typical ranges: 2-3 months for protocol development and CDSCO submission; 1-2 months for site initiation and EC approvals; 6-18 months for enrolment depending on size; 3-6 months for follow-up and database lock; 2-4 months for final CSR. CDSCO typically specifies the overall completion timeline at the time of drug approval, and our project plans are built backward from that deadline.
Does Auriga handle publication and manuscript writing for RWE studies?
Yes. Auriga's medical writing team prepares peer-reviewed journal manuscripts and conference abstracts from RWE study data, following ICMJE and GPP3 guidelines. Multiple manuscripts from our active PMO and RWS programmes are currently in progress for peer-reviewed publication. Publication support can be engaged independently or as part of the full study scope.

Plan Your PMO or RWE Study

CDSCO PMO commitments under NDCT Rules 2019 · 370 investigator sites · Clinevo EDC · OnePharmacovigilance · Up to 5,000-subject, 500-site execution experience.

+91-7428116100 Request an RWE Proposal

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