Part of the Trialion platform — one login, one audit trailEDC & eCRF
Drag fields onto the form and the study is built — no programming, no vendor ticket. Edit checks, derivations and visit schedules run from the first subject, so the data lands clean.
What EDC / eCRF does, end to end.
Every stage of the trial data lifecycle, on one platform — designed, captured, reviewed, and locked under one continuous audit trail.
Design
Visual study build in days, not months.
- Drag-and-drop eCRF designer with conditional logic
- Pre-built BA-BE templates (replicate-design, PK sampling)
- Visit schedules for parallel, crossover, and adaptive designs
- Edit checks and derivations without writing code
- Protocol amendments deploy without a full study rebuild
Capture
Clean data from the first entry.
- Real-time edit checks at the point of data entry
- Automated queries with full audit attribution
- Mobile-first capture for coordinators at low-connectivity sites
- Offline capture that syncs cleanly on reconnect at low-bandwidth sites
Review
Data managers stay ahead of the queue.
- Inline query resolution across forms and visits
- Configurable data review listings, metrics, and reports
- RBQM signals surfaced inside the data-review workspace
- Open / answered / closed query throughput dashboards
Lock & Export
CDSCO and CDISC submission-ready closeout.
- Controlled data freeze and database lock workflows
- 21 CFR Part 11–style e-signatures with full attribution
- CDSCO Schedule Y submission packs from the same data model
- CDISC ODM / SDTM and ANDA-ready exports for international filings
- Scheduled exports to warehouses, BI, and submission pipelines
The same EDC, from build to lock.
Four views, one continuous data model — and one audit trail under every action.
Architected for audit, from day one.
The Trialion EDC is designed for Indian GCP and aligned to CDSCO New Drugs and Clinical Trials Rules, 2019. Role-based access, electronic signatures, and an immutable audit trail are built into the platform from the outset. Personal data is processed in alignment with the DPDP Act 2023, on infrastructure that encrypts data in transit and at rest and logs every access. The formal computer system validation exercise runs with an external auditor, and we tell every customer exactly where that stands.
Every action across the EDC lands on one immutable audit trail — not a fragmented log per module or per vendor.
Migrating from your existing EDC?
Our migration team runs a standard 4–6 week playbook for moving studies — including bioequivalence volunteer records, eCRFs, queries, and the audit trail — from your existing EDC or paper-based workflows onto Trialion. Most migrations proceed without pausing site activity.
Frequently asked
Where is the data hosted?+
Customer data is processed in alignment with the DPDP Act 2023. The underlying cloud infrastructure encrypts data in transit and at rest, enforces role-based access, and logs every access for audit. Enterprise customers can opt in to a dedicated single-tenant environment or regional failover; the full subprocessor list is published in our Data Processing Agreement.
How does this work for coordinators at low-connectivity sites?+
Mobile-first capture stores entries locally when connectivity is unreliable and synchronises on reconnect. Audit attribution preserves the original capture timestamp. The same workflow operates from a laptop at a metro site or a smartphone at a district hospital.
Do sites need to install anything?+
No. Trialion is browser-based — Chrome, Edge, Safari, and Firefox — plus the mobile capture app for low-connectivity workflows. No client software, no per-machine deployment.
How fast can we see it on our own protocol?+
We provision a sandbox configured against your study design in under 24 hours — including bioequivalence templates where applicable. Book a demo and our Gurugram team handles the intake.
How is this priced?+
Per active study or per month. No per-form, per-query, or per-export fees. See /pricing for tiers.