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AI-native EDC · built by BITS Pilani and IQVIA alumni

The AI-native EDC built for strict compliance and zero lag

Accelerate study start-up from weeks to days. Protocols translate into edit-check-ready eCRF drafts, lab reports ingest instantly, and audit-ready queries are drafted by AI — always reviewed, signed and locked by a qualified person.

See it on your protocolHow it works

AI Designer

Protocols translated into edit-check-ready eCRFs in minutes, not weeks.

AI Capture

Instant lab ingest: values lifted from central lab reports with full source-to-data traceability.

Immutable audit trail

Every change attributed and time-stamped, designed for 21 CFR Part 11, CDSCO and DPDP.

  • CDSCO Schedule Y
  • Indian GCP
  • ICH E6(R3)
  • 21 CFR Part 11
  • CDISC SDTM
  • DPDP Act 2023
How it works

Step by step breakdown

Tired of rebuilding every study by hand? Draft, capture, check, sign — in four steps.

  1. A doctor writing notes while a patient sits opposite1
    14 fields drafted from §7.2AI DesignerReview pending

    Draft

    Point the AI Designer at your protocol section. It instantly drafts the structured fields, validation logic and edit checks for CRA and DM review.

  2. A doctor taking a patient's blood pressure2

    Reading central lab report

    • Haemoglobin 13.4 g/dLConfidence 99%
    • Platelets 228 ×10⁹/LConfidence 98%
    • ALT 41 U/LConfidence 96%

    Capture

    Upload source documents or lab reports. AI Capture lifts values directly into fields, tagging every extraction with a confidence score for rapid verification.

  3. 3
    9:41Trialion

    Edit check

    Visit 2 · Vital signs

    • SubjectSUBJ-00482
    • CheckCHK-003
    • Systolic148 · above range
    • QueryDrafted

    Waiting for the data manager

    Check

    Automated edit checks fire instantly as data lands. Discrepancies generate pre-drafted queries, saving data managers hours of manual tracking.

  4. A clinician signing a form on a clipboard4
    21 CFR Part 11
    DraftedReviewedSigned

    Sign

    Nothing goes live or locks without explicit human sign-off. Every signature is written to the trial's permanent audit trail.

Amendments

Live, versioned, without a rebuild

Amend mid-study in hours, not weeks.

The live study keeps running on its current version while the amendment is drafted, tested and signed beside it. No pause, no freeze, no migration.

LIVE · v1.0 · Site 04, Visit 3 · entering dataLIVE · v1.1 · effective 12:05 · sites uninterrupted
Amendment
Protocol amendedDraft

v1.1 is drafted beside the live study. v1.0 keeps running at every site.09:12

Test
Test the changeTest subjects

Only what changed is exercised: entry, checks, derivations and export. Test data never touches production.10:40

Review
A data manager reviews the deltaSign

Reviewer, timestamp and the value before and after go to the audit trail.12:05

Signed
Promote to liveLive

v1.1 takes effect from its date. Sites keep entering, nothing is re-entered, nothing migrates.12:05

Not signed
Back to draftDraft

Nothing reaches a site without a qualified name on it. The live version is untouched.

A typical amendment: two fields, one edit check and a visit window. About three hours from amended protocol to live, with sites entering data throughout.

Features

Run every study on one data model.

Build it without code.

Drag fields onto the form, set the conditional logic and add edit checks. The AI is optional, and every draft it proposes can be taken apart the same way.

  • Edit checks at entry
  • Queries in one workflow
  • e-Signatures, freeze & lock
  • Amendments without a rebuild

Open at the edges.

Your CTMS, eTMF, eConsent, RTSM and safety database connect once, at the boundary. Every field carries its SDTM mapping from the day it is designed, so statistics gets a clean handoff on the day of lock, not six weeks after it.

  • CTMS
  • eTMF
  • eConsent
  • RTSM / IWRS
  • Safety database
  • SDTM export
  • define.xml
Testimonials

What a data manager said after the build.

Explore solutionsBook a demo
“Most systems we looked at were built for a trial that does not look like ours. Trialion starts from Schedule Y, and from what a coordinator at a remote site can realistically do on the day. The audit trail is the part that holds up when an inspector starts asking.”
Sushant SinghFounder, Clinical Veda
  • 30 minutesTo see it running on your own protocol
  • 10 minutesTo stand a study build up end to end
  • No codeTo build your forms, checks and visit schedule
  • OneData model behind every module
Before a build

The questions we get asked first.

Answered as we would answer them on a call, including the ones where the answer is not yet.

What environments do I get, and can test data reach production?

Today a study moves draft → UAT → live, and configuration is promoted between them. A separate development environment and an independent QC stage, with test subject data isolated from production, is the next piece of architecture we are building. If you are planning a build, ask us where it stands on the day.

Show me a mid-study amendment with subjects already enrolled.

Amendments version the study configuration and deploy without a rebuild. What we will not claim yet is a complete change-control workflow across separate environments, with a documented impact on already-enrolled subjects. Bring the scenario to the call and we will walk it honestly rather than demo around it.

How is my study validated, separately from your platform?

They are two different things and we keep them separate. Platform validation is ours: the system is architected to GAMP 5 and the formal exercise runs with an external auditor. Study validation is proving that your CRFs, edit checks, derivations and visit structure behave to your specification — today that happens in UAT, and a dedicated QC stage with retained evidence is in build.

Can we configure roles beyond PM, DM, CRA, CRC and PI?

Yes. Roles and their permissions are configurable rather than fixed, at organisation, study and site level, because no two CROs use the same titles. Field- and form-level restriction is the next level of granularity and is not there yet.

What happens when a required field genuinely cannot be filled?

Today it raises a query, and that is wrong — a deliberate blank is not a discrepancy. Standardised missing-data reasons (not done, not applicable, unknown, not available) recorded with a comment on the audit trail are a change we are making, because statistics needs to tell an omission from a fact.

Do we have to use the AI?

No. A study can be built entirely by hand, and nothing the model drafts takes effect until a person accepts it. The AI writes a proposal; a qualified reviewer decides whether it becomes the study.

What is retained about an AI-drafted form?

The generated output, every human change made to it afterwards, and who approved it are on the audit trail. Retaining the model version and the prompt alongside them is a change in progress, so an inspector can see what was proposed as well as what was accepted.

Do you support blinded studies?

Not today. Trialion is built for open-label work, including bioequivalence and Phase I–IV designs that randomise without blinding. Blinding touches randomisation, drug supply, unblinded pharmacy roles and emergency unblinding at once, and we would rather say no now than ship something that leaks a treatment assignment.

Contact now

See it on your protocol today.

Bring your protocol for a 30-minute walkthrough and have your sandbox live in 24 hours. No scoping call, no quote and no purchase order first.

Book a demoSee pricing
  • CDSCO Schedule Y
  • Indian GCP
  • ICH E6(R3)
  • 21 CFR Part 11
  • CDISC SDTM
  • DPDP Act 2023