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What the EDC connects to

One EDC. Open at the edges.

Trialion is the EDC. Everything else a trial runs on — consent, randomisation, site management, safety, coding — is a system you already have, and the EDC connects to it once, at the boundary.

By system

Your systems, connected to one data model.

Each category below names the kind of system on the other side of the connection. Whichever you run, its data lands on the same audit trail and subject record as the EDC — and stays yours.

CTMS systems

CTMS

Site activation, milestones and monitoring visits stay in the CTMS you run. Study, site and subject status flow both ways, so a monitor sees the same enrolment the EDC does.

Your existing CTMSIn-house CRO operations systems

eTMF systems

eTMF

Documents and their metadata sync with your eTMF, or with the shared-drive folder you call one. Completeness tracking and zone mapping follow your DIA reference model.

Your existing eTMFShared-drive document roomsIn-house TMF systems

eConsent platforms

eConsent

Remote, in-clinic and hybrid informed consent runs on the eConsent platform you choose — or on scanned paper ICFs for low-connectivity sites — with the signed ICF on the same audit trail as the EDC record.

Established eConsent providersPaper-based ICF flows

ePRO / eCOA platforms

ePRO / eCOA

Patient-reported outcomes and clinical assessments land on the subject record from the ePRO or eCOA platform the study uses, including mobile-first capture for low-bandwidth sites.

Established ePRO / eCOA providers

RTSM / IWRS systems

RTSM / IWRS

Randomisation and trial-supply management connect via IRT. Assignments and kit dispensing are mapped to the volunteer record in the EDC, which is what a BA-BE replicate design needs reconciled.

Established RTSM / IWRS providersIn-house RTSM workflows

Safety databases

Safety database

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

Your existing safety databaseRegulatory reporting gatewaysICH E2B(R3)

Medical coding tools

Medical coding

Verbatim terms are coded in your MedDRA and WHODrug tooling; the assignments flow back onto the subject record with their full audit history.

MedDRA and WHODrug dictionariesMedDRAWHODrug

RBQM and central monitoring tools

RBQM & central monitoring

Risk signals and central monitoring run in the RBQM tool you already use, fed from the EDC. Queries keep flowing through the EDC's single query workflow.

Established RBQM platformsIn-house QMS

Getting data out

Leaving is an export, not a project.

Domains build to CDISC SDTM structure from the data as captured, not from a mapping exercise at the end. Statistics gets a clean handoff, and so does anyone who decides to take their study elsewhere.

And every other connection

Plus the data sources, exports and BI tools every trial needs.

CTRI registration
central labs
Hospital information systems
IRT / IWRS
Safety databases (E2B(R3))
CDISC pipelines
BI dashboards
Data warehouses

CDSCO & regulatory

  • CTRI registration support (in build)
  • CDSCO Form CT-04 / CT-21 submission packs
  • DCGI / DBT-funded study workflows

Clinical data sources

  • Central laboratories, by report feed or PDF through AI Capture
  • Hospital information systems via HL7 FHIR
  • Imaging and read-workflow vendors

Analytics & data warehouse

  • CDISC SDTM submission pipelines
  • BI tools, by scheduled export or live connector
  • Cloud data warehouses, in-region

Not listed?

Need a connection we haven’t named?

Our integrations team builds and maintains the connections sponsors and CROs depend on. Tell us your stack and we will come back with a plan.

Talk to the integrations teamSee the EDC