Audit-ready by design.Not after the fact.
One data model, one audit trail, CDSCO-aligned end-to-end. Designed for Indian GCP and aligned to ICH E6(R3) for international filings.
CDSCO Schedule Y, end-to-end
Study templates, the audit trail, and electronic signatures are designed for Indian GCP and aligned to CDSCO New Drugs and Clinical Trials Rules, 2019. CTRI registration via SUGAM is in build.
Part 11–style e-signatures
Compliant electronic signatures with meaning, attribution, and reason-for-change — recognized by Indian GCP, ICH E6(R3), and 21 CFR Part 11 for international filings.
Validation pack on day one
Every environment ships with IQ/OQ/PQ documentation, validation scripts, and a dedicated validation engineer at go-live. Your QA team re-runs only the protocol-specific PQ.
Security by default
Encryption in transit and at rest, granular role-based access, SSO/SAML, and least-privilege permissions. ISO 27001 controls aligned and tested.
Data residency
All customer data is processed in alignment with the DPDP Act 2023. The underlying cloud infrastructure operates on controls aligned to ISO 27001, ISO 27017, and ISO 27018. Enterprise customers can opt in to dedicated single-tenant environments or regional failover; the full subprocessor list is published in our Data Processing Agreement.
Standards, end to end
CDSCO Schedule Y · ICMR National Ethical Guidelines (2017) · Indian GCP · DPDP Act 2023 · ICH E6(R3) · ICH E2A and E2B(R3) for safety · CDISC ODM / SDTM · MedDRA / WHODrug · HL7 FHIR for integration.
Bring your QA, regulatory, and ethics-committee teams to the demo.
We walk through the audit trail, electronic signatures, validation approach, CTRI registration support, and DPDP-aligned data handling in detail — the elements that determine the outcome of an Indian-GCP inspection.