Live in India.Open at the edges.

Site activation, milestones, monitoring visits, and CDSCO submission tracking are delivered through bidirectional integration with your existing CTMS while we build the native module. CTRI registration via the SUGAM portal lands as part of this milestone.

Documents and metadata sync with your existing eTMF (or the SharePoint folder you call one); completeness tracking and TMF zone mapping mirror your DIA reference model until the native module ships.

Remote, in-clinic, and hybrid informed consent is delivered through supported eConsent partners — or scanned-paper ICF flows for tier-2/3 sites — with signed ICFs on the same audit trail as the EDC.

Patient-reported outcomes and clinical assessments flow into the trial data model via integrated ePRO/eCOA platforms — including mobile-first capture for low-bandwidth sites.

Randomization and trial supply management connect via IRT; randomization assignments and kit dispensing are mapped to the volunteer record in the EDC — critical for BA-BE replicate-design studies.

Adverse and serious adverse events captured in the EDC reconcile and hand off cleanly to your safety database via ICH E2B(R3), with India PvPI reporting flows where applicable.

Verbatim terms can be coded with your existing MedDRA and WHODrug tooling; assignments flow back onto the subject record with full audit history.

Risk signals and central monitoring connect via integrated RBQM tools; queries continue to flow through the EDC's single query workflow.