Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Clinical Trial Site Management India | 370 Sites · 100+ SMO Partners

Auriga's site network spans 370 investigator sites across India — East (85 sites) across West Bengal, Odisha, Jharkhand, Assam; West and Central (117 sites) across Gujarat, Rajasthan, Maharashtra, Madhya Pradesh, Chhattisgarh; North (78 sites) across Delhi, Uttar Pradesh, Haryana, Punjab, Bihar, Himachal Pradesh; and South (90 sites) across Andhra Pradesh, Telangana, Tamil Nadu, Karnataka, Kerala. Plus 100+ SMO collaborations. Therapeutic area and geography-specific site selection is run by a dedicated Site Selection Team.

Operations run on OneClinicalTrials CTMS — CTMS-driven site qualification, milestone tracking, investigator payments, and patient recruitment/randomisation. Clinevo EDC for site data entry. rSDV for remote source data verification, reducing on-site monitoring trips and sponsor travel cost. All compliant with ICH E6(R3), 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR.

Auriga manages EC dossiers, IEC fees, CTRI registration, and IP management end-to-end — sponsors do not coordinate site-by-site with each Ethics Committee, depot, or randomisation desk. Site quality is built through the Site Excellence Forum — 4 SOP training programmes delivered to investigator sites to date covering patient screening, recruitment, ISF maintenance, and informed consent.

Request an SMO Proposal Call +91-7428116100

370 Investigator Sites · 4 Zones · 15+ States

A site database engineered for therapeutic area and geography-specific selection — answer the sponsor question "Do you have sites in my therapeutic area and my region?" before the first call ends.

85
East

West Bengal · Odisha · Jharkhand · Assam

117
West & Central

Gujarat · Rajasthan · Maharashtra · Madhya Pradesh · Chhattisgarh

78
North

Delhi · Uttar Pradesh · Haryana · Punjab · Bihar · Himachal Pradesh

90
South

Andhra Pradesh · Telangana · Tamil Nadu · Karnataka · Kerala

370

Investigator sites

100+

SMO partnerships

15+

States covered

4

SOP training sessions (Site Excellence Forum)

Technology Backbone

Site management runs end-to-end on Auriga's integrated digital platform — purpose-built for ICH E6(R3) risk-based oversight.

OneClinicalTrials CTMS

Site qualification, milestone tracking, investigator payments, IP inventory, and patient recruitment / randomisation — all in one source of truth.

Clinevo EDC

Electronic data capture for site data entry, edit checks, MedDRA coding, IWRS randomisation, and CDISC-aligned exports for biostatistics.

rSDV Portal

Remote source data verification with masked access, watermarking, and download controls — reduces sponsor travel cost without losing oversight.

All systems compliant with ICH E6(R3), 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR.

SMO Service Capabilities

End-to-end site operations from feasibility through close-out — sponsors do not coordinate site-by-site with ECs, depots, or randomisation desks.

Site Identification & Feasibility

Therapeutic area and geography-specific selection from our 370-site network — investigator experience, patient population access, GCP infrastructure, regulatory track record, and prior study performance.

EC Dossier & CTRI Workflow

Independent Ethics Committee dossier compilation, IEC fee management, and CTRI prospective registration — Auriga manages each site's EC submission so sponsors do not coordinate site-by-site.

Investigational Product (IP) Management

Receipt and secure storage of investigational products from the sponsor, randomisation, IWRS setup, and shipment to investigator sites with full CTMS inventory tracking and chain-of-custody documentation.

Patient Recruitment & Retention

Multi-channel recruitment via physician referral networks, patient databases, community outreach, and digital campaigns. Weekly enrolment tracking with contingency-site activation when targets slip.

CRC Staffing & Training

Trained clinical research coordinators deployed on-site for consent administration, EDC data entry, source document maintenance, AE/SAE reporting, and regulatory binder management.

Site Initiation & Close-Out

Site qualification visits, GCP and protocol-specific training under ICH E6(R3), IP accountability setup, EDC and IWRS training, source document preparation, and systematic close-out with document archiving.

Monitoring — On-site & Remote (rSDV)

On-site source data verification at risk-based monitoring triggers and remote SDV through Auriga's rSDV portal — reduces sponsor travel costs while maintaining ICH E6(R3) oversight.

Investigator Payments

CTMS-driven milestone-based investigator payment processing, GST and TDS handling, and audit-traceable site fee reconciliation.

Site Excellence Forum

Auriga's ongoing investigator training programme — to date, 4 SOP training sessions delivered to sites covering patient screening, recruitment, ISF maintenance, informed consent, and AE/SAE reporting.

Site Excellence Forum

Auriga runs an ongoing investigator training programme — the Site Excellence Forum — that has delivered 4 SOP training sessions to investigator sites across India. Site quality is built, not just selected.

Patient Screening & Recruitment

Inclusion/exclusion application, patient identification, recruitment fairness, and consent process before screening.

ISF Maintenance

Investigator Site File structure, essential document filing, regulatory binder upkeep, and inspection-readiness.

Informed Consent Procedures

ICH E6(R3) informed consent process, eICF where applicable, re-consent triggers, and documentation of the consent discussion.

AE / SAE Reporting

Adverse event capture, seriousness/severity grading, expedited SAE reporting, and Sugam portal SAE submission timelines.

Related Services

CRO Services Overview Full CRO capabilities Phase II–IV Trials CDSCO CRO · documented experience Biostatistics & Data ICH E9(R1) · CDISC · SAS + R Pharmacovigilance OnePharmacovigilance · PSUR · DSUR Medical Writing PSUR · DSUR · eCTD · Manuscripts BA/BE Monitoring & PK Independent monitoring · Phoenix WinNonLin

Frequently Asked Questions

How many investigator sites does Auriga work with?
Auriga's site network spans 370 investigator sites across India: 85 in the East (West Bengal, Odisha, Jharkhand, Assam); 117 in West and Central India (Gujarat, Rajasthan, Maharashtra, Madhya Pradesh, Chhattisgarh); 78 in the North (Delhi, Uttar Pradesh, Haryana, Punjab, Bihar, Himachal Pradesh); and 90 in the South (Andhra Pradesh, Telangana, Tamil Nadu, Karnataka, Kerala). We also collaborate with 100+ SMO partners. Site selection is therapeutic-area and geography-specific, managed by our dedicated Site Selection Team.
What technology backs Auriga's site management?
Site management runs on Auriga's integrated digital platform: OneClinicalTrials CTMS for site qualification, milestone tracking, investigator payments, and patient recruitment/randomisation; Clinevo EDC for site data entry and edit checks; and the rSDV portal for remote source data verification — reducing on-site monitoring trips and sponsor travel costs. All systems are 21 CFR Part 11, EU GMP ANNEX 11, GxP, and GDPR compliant.
Does Auriga manage Ethics Committee submissions and CTRI registration?
Yes. Independent Ethics Committee (IEC) dossier compilation, IEC fee management, site EC submissions, and CTRI prospective registration are all managed by Auriga's site management team. Sponsors do not need to coordinate separately with each site's EC — this removes a major operational burden that sponsors often underestimate at the proposal stage.
Does Auriga handle Investigational Product (IP) management?
Yes. We receive investigational products from the sponsor, store them under validated conditions (temperature-controlled where required), perform randomisation, and ship to each investigator site with full CTMS inventory tracking and chain-of-custody documentation. IP accountability, dispensing logs, and final reconciliation are managed through CTMS — audit-traceable end to end.
What is the Site Excellence Forum?
The Site Excellence Forum is Auriga's investigator training programme that improves site quality across our network. To date, the Forum has delivered 4 SOP training sessions covering patient screening and recruitment, Investigator Site File (ISF) maintenance, informed consent procedures, and AE/SAE reporting. Site quality is built, not just selected.
How does Auriga handle patient recruitment delays?
Patient recruitment is where most clinical trials face delays. Our team tracks enrolment weekly against the planned curve; below-target sites get focused intervention (training, recruitment materials, awareness campaigns) and contingency sites are activated when sites consistently underperform. Multi-channel recruitment (physician referrals, patient databases, community engagement, digital outreach) is run from study start, not deferred to mid-study.
Does Auriga provide Clinical Research Coordinators (CRCs)?
Yes. Auriga employs trained CRCs deployable to investigator sites for the study duration. CRCs handle informed consent administration, visit scheduling, EDC data entry, source document completion, AE/SAE reporting, specimen collection coordination, and regulatory binder maintenance. All CRCs are GCP-trained under ICH E6(R3) and experienced in therapeutic-area-specific protocols.
Is rSDV (remote source data verification) accepted by CDSCO?
Yes — when implemented under ICH E6(R3) risk-based monitoring with appropriate data privacy controls. Auriga's rSDV portal provides masked, audit-traceable remote SDV with role-based access, watermarking, and download restrictions. Sponsors and inspectors retain full access to source documents while reducing physical monitoring trips by 40-60% on most studies.

Activate Clinical Trial Sites Across India

370 investigator sites · 100+ SMO collaborations · OneClinicalTrials CTMS · Clinevo EDC · rSDV · IP management · EC dossier + CTRI workflow handled end-to-end.

+91-7428116100 Request an SMO Proposal

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