Integrations
Modern studies run across EDC, CTMS, eTMF, safety, labs, identity, site source, and reporting tools. Clinistack connects those systems around the trial work itself: what changed, who owns the record, who has to review it, and what evidence explains the decision.
Every exchange starts with a plain record map: record type, study scope, source system, owner, and allowed action. Teams should never have to guess whether Clinistack is reading, reconciling, or changing a regulated record.
Missing documents, stale protocol versions, subject mismatches, failed imports, duplicate safety signals, and late lab updates become review queues with owners, status, and disposition instead of spreadsheet cleanup.
Runs, approvals, exceptions, retries, and reviewer decisions stay attached to the connection so clinical operations, quality, IT, and inspection teams can see why the result is safe to rely on.
Migration and standards mapping
Bring an existing crosswalk or have us build one with your data team. Clinistack supports vendor exports, REDCap or EDC structures, spreadsheets, historical records, and study metadata moving toward the standard your trial work needs: CDISC capture and submission models, FHIR/source data, lab terminology, safety terminology, or TMF context.
Messy source data does not mean improvised import. If the source is a legacy database, a vendor export, a mixed REDCap and EDC history, a spreadsheet collection, or a format nobody has documented well, we work through it with you: profile the source, choose the target standard, review the exceptions, rehearse the load, and keep the release evidence together.
Use this path for vendor exports, REDCap or EDC histories, spreadsheets, and other sources that need controlled import.
Plan a migration rehearsalMap source fields to CDASH, ODM, SDTM, ADaM, Define-XML, FHIR, LOINC, MedDRA, WHODrug, or TMF context where that standard belongs.
Protocol, form, dataset, terminology, document taxonomy, and vendor-package versions stay visible with the mapped record.
Dry runs expose duplicates, missing values, stale protocol state, invalid owners, failed transforms, and review work before import.
Production migration keeps mapping version, source extract, transform rules, exception disposition, reviewer approval, and run history together.
Go-live evidence
Name the trial action the exchange changes: review, migration, reporting, safety intake, access, or inspection response.
Document the system of record, allowed action, data class, study scope, owner, and approval route.
Use fixture payloads and rehearsal runs to expose bad records, stale context, duplicate entries, and failure handling.
Attach mapping, approval, test results, exception routes, and run history to the connection before go-live.
Keep status, retry behavior, review owners, pause controls, and inspection evidence visible after go-live.
Proof before production
A record-ownership map for every object the connection reads, reconciles, exports, or changes.
An access route with credential custody, tenant boundary, study scope, and data class made explicit.
Mapping and transform rules that a clinical, data, quality, or IT reviewer can understand later.
Test payloads or rehearsal output that prove normal, error, retry, exception, and pause behavior.
Review queues that show who owns each mismatch, failure, duplicate, or unresolved record.
Run history and release evidence that can be replayed during diligence, release review, or inspection.
Common questions
Bring the system, access method, export or standard, and the trial work you want to change. We will review the controlled route around that work.
No. Clinical teams need clear record ownership. Clinistack can operate across systems while preserving which one owns each record.
Writeback is scoped separately from read and reconciliation. It needs explicit owner approval, release evidence, and controls strong enough for the record being changed.
Exports can still be useful when frequency, ownership, mapping, exception handling, and review workflow are explicit.
Migrations use rehearsal loads, mapping review, exception disposition, source extracts, approval, and cutover evidence instead of silent imports.
They stay with the mapping context so reviewers can see which package, vocabulary, and protocol version informed the record.
System exchange
We will review the source record, allowed action, review queue, evidence, and release path needed to make the exchange useful in real trial operations.