Part of the Trialion platform — one login, one audit trailEDC & eCRF
A drag-and-drop study builder and electronic case report forms with edit checks, derivations, and visit schedules — capturing clean data from the first subject.
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 tier-2 and tier-3 site coordinators
- 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.
EDC / eCRF in three steps
Design
Build forms, edit checks, derivations, and visit schedules in a visual designer — no programming required.
Capture
Sites enter data with real-time validation that catches errors at the point of entry, not weeks later.
Review
Data managers resolve queries inline, with every change recorded on one continuous audit trail.
Validated and audit-ready, day one.
The Trialion EDC is designed for Indian GCP and aligned to CDSCO New Drugs and Clinical Trials Rules, 2019. Every environment ships with IQ/OQ/PQ documentation, role-based access, electronic signatures, and an immutable audit trail — built into the platform from the outset. Personal data is processed in alignment with the DPDP Act 2023; the underlying infrastructure operates on cloud controls aligned to ISO 27001, ISO 27017, and ISO 27018. QA teams receive the validation pack at kickoff and re-run only the protocol-specific PQ.
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 Indian 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 operates on controls aligned to ISO 27001, ISO 27017, and ISO 27018. 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.
Is the EDC aligned to CDSCO Schedule Y?+
Yes. 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 support via the SUGAM portal is in build.
Does the EDC support BA-BE studies?+
Yes. Pre-built bioequivalence templates include replicate-design support, dosing-interval and PK sampling schedules, integrated volunteer-to-dispensing workflows, and ANDA-ready exports for international filings.
How does this work for coordinators at non-metro 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.
Is the platform aligned to the DPDP Act 2023?+
Yes. Processing flows surface explicit consent capture, and our Data Processing Agreement covers DPDP-required notice and grievance redress mechanisms. See /dpa for details.
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.
Can we migrate from Octalsoft, Castor, or paper?+
Yes. Our migration playbooks cover the principal Indian EDCs (Octalsoft, Castor India, MaxisIT, Datatrak) as well as paper and Excel data rooms. Typical migration is 4–6 weeks and generally proceeds without pausing site activity.
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.