Modern EDC · Built for Indian CROs

Clinical trials,simplified.

The new standard for clinical research in India. Built by data managers. Engineered by AI.

Trialion launches with the EDC live today on a unified data model. Coming next: eConsent, ePRO / eCOA, CTMS, eTMF, RTSM, Safety, Medical Coding, Data Quality & RBQM.

Designed for & aligned with
CDSCO Schedule YIndian GCPICMR (2017)DPDP Act 2023CTRI registrationICH E6(R3)21 CFR Part 11CDISC ODM / SDTMISO 27001 / 27017 / 27018 alignedSOC 2 Type II aligned

Outcome snapshots — illustrative results

Veridian Clinical
Database lock cut from 12 weeks to 7 across 3 BA-BE studies
Pinnacle BA-BE
Site activation reduced to 11 days median
Asterix Trials
Automated edit checks engineered by data managers to kill manual queries.
Caduceus India
CDSCO submission packs assembled in hours, not weeks
Helika Biostudies
Tier-2 sites moved from paper CRFs to mobile-first capture
Indus Trial Sciences
Imported USD-quoted EDC replaced at one-third the cost
The problem

Clinical research runs on tools designed elsewhere.

Imported EDCs ignore bioequivalence. Domestic alternatives lack audit-trail rigour. Trialion bridges both.

01

Vendor fragmentation across BA-BE pipelines.

Volunteer recruitment in one system, randomization in another, dispensing in a third, eCRFs in a fourth — with reconciliation in spreadsheets.

02

Paper workflows at non-metro sites.

Limited connectivity at sites outside Tier-1 metros pushes coordinators back to printed CRFs and manual transcription.

03

Foreign-currency contracts against rupee-denominated trials.

Imported eClinical platforms quote in foreign currency against rupee trial budgets — creating margin pressure that is particularly acute for high-volume generics work.

Our DNA

Built by the Industry, For the Industry.

Legacy systems are built by software companies translating clinical research. Trialion is built by data managers who have shipped the lock, partnered with AI engineers who reduce the work to get there.

Build, in minutes

Drag. Drop. Done.

An eCRF designer engineered to feel inevitable. Field types, conditional logic, edit checks — assembled without writing code.

  • · Conditional logic without programming
  • · Edit checks at the point of entry
  • · Amendments deploy without a rebuild
The shift

Built for compliance. Engineered for operations.

The legacy stack
EDCCTMSeTMFePRORTSMSafety
  • Foreign-currency contracts against rupee-denominated trials
  • Imported EDCs without native bioequivalence support
  • Paper capture at non-metro sites
  • Multi-portal workflows per volunteer
  • Data hosted outside India
  • Extended validation cycles before study start
The Trialion approach

Start with the EDC. Integrate the rest. Inherit the platform as it lands — no re-platforming.

EDCCTMSeTMFRTSMSafetyePRO
  • BA-BE templates structured exactly how a data manager would build them—ready on day one.
  • Mobile-first capture with offline sync for low-bandwidth sites
  • DPDP Act 2023 and ISO 27001 / 27017 / 27018 aligned
  • Aligned to CDSCO Schedule Y, ICH E6(R3), and Indian GCP
  • Single vendor accountable from first entry to database lock
The unified platform

EDC live. The rest on the roadmap.

One data model. One audit trail. Native modules ship onto the same foundation.

AI engineers train the Data Quality & RBQM modules. Data managers validate eTMF against ICH E6(R3). You’re not buying an EDC — you’re gaining an extension of your team.

One continuous trial

The same platform, from setup to database lock.

No hand-offs between vendors. No export-and-reimport. Watch one data model carry the trial end to end.

During Setup, these modules are working:

Same data, same audit trail — no export, re-import, or reconciliation between stages.

Built for every role

One platform that works the way each team does.

Sponsors, CROs, data managers, investigators, coordinators, and PV — one login, tailored to the job.

Sponsor ClinOps

Program-wide oversight, cycle time, and vendor consolidation in a single dashboard.

app.trialion.com
Portfolio oversight — 6 studies, lock forecast

Compliant by design — not as a bolt-on.

Audit trails, electronic signatures, and validation are built into every module.

CDSCO Schedule YIndian GCPICMR (2017)DPDP Act 2023CTRI registrationICH E6(R3)21 CFR Part 11CDISC ODM / SDTMISO 27001 / 27017 / 27018 alignedSOC 2 Type II aligned
Integrations

Connected to the stack you already run.

CTRI via SUGAM, CTMS, eTMF, RTSM, safety, central labs, BI. No rip-and-replace.

CTRI registration
SUGAM portal (CDSCO)
Indian central labs
Hospital information systems
IRT / IWRS
Safety databases (E2B(R3))
CDISC pipelines
Power BI
Tableau
DPDP Act 2023
Aligned by design
Schedule Y
CDSCO-aligned by design
ISO 27001
Information security controls aligned
“We replaced five vendors with Trialion and locked our last study 42% faster. The audit trail alone changed how our inspections go.”
VP, Clinical Operations · mid-stage biotech

See it on your protocol.

30 minutes. No slideware. Sandbox in 24 hours.