IVD manufacturers
Run European performance studies without forcing an IVD protocol into a generic drug-trial workflow.
RT CLINICA · EDC / eCRF FOR IVD PERFORMANCE STUDIES
Clinical data capture built around the IVD evidence workflow.
RT Clinica connects study setup, protected eCRF capture, data review, signatures, lock and traceable export in one English- and Italian-language platform — designed around European IVD performance studies, not adapted from a generic trial template.
RT ClinicaStudy workspaceEN / IT
IVD PERFORMANCE STUDYStudy readiness
Data capture Review Signed
Illustrative interface — no patient or customer data shown.
WHO IT IS FOR
One platform for the organisations that produce IVD evidence.
Available as a dedicated software product or as the controlled data layer within a separately scoped FirsTeckBio CRO engagement.
Specialist CRO teams
Configure studies, sites, roles and review workflows while keeping every change and decision traceable.
Clinical sites & data managers
Capture and review pseudonymised study data in English or Italian, with a tablet-ready entry experience.
FROM PROTOCOL TO INSPECTION PACKAGE
The study data chain stays connected.
Each stage preserves the context needed by the next one, without spreadsheet hand-offs.
- 01
Design
Versioned eCRFs, visit schedules, eligibility logic, edit checks and acceptance criteria.
- 02
Capture
Pseudonymised subject registration and protected online data entry across study sites.
- 03
Review
Queries, source-data verification, clinical review, medical coding and data-cleaning oversight.
- 04
Sign & lock
Content-bound electronic signatures, controlled invalidation and record/database freeze.
- 05
Export
CDISC ODM, SDTM, Excel and CSV outputs, plus a manifest-backed inspection package.
CAPABILITIES RUNNING TODAY
More than electronic forms.
The platform covers capture, cleaning, review and export work that specialist IVD studies normally split across multiple tools.
Study setup & immutable versions
Study, site, form and visit configuration with controlled publishing and versioned form snapshots.
IVD data capture
Server-side edit checks, calculated fields, eligibility rules and configurable acceptance criteria.
Queries, SDV & review
Field-level conversations, review states and automatic SDV invalidation after a data change.
Performance-study analytics
Method-comparison and study-readiness views connected to the underlying captured records.
Specimens, safety & coding
Traceable specimen workflows, study safety records and medical-coding support in the same scope.
IRT, ePRO & monitoring
Optional randomisation, participant invitations and CTMS-style monitoring records for suitable studies.
DATA INTEGRITY BY DESIGN
Controls that can be demonstrated — with clear validation boundaries.
RT Clinica includes technical controls designed to support 21 CFR Part 11, EU Annex 11, GDPR-aligned operation and IVD study use. The software is not “FDA certified” or “EU certified”; each deployment still requires its applicable procedures, approvals and study-specific PQ/UAT.
Database-enforced audit trail
Append-only, per-field audit records with server time, actor and mandatory reasons for clinical corrections.
Scoped access & tenant isolation
Study/site role permissions backed by PostgreSQL row-level security and MFA-capable identity controls.
Content-bound signatures
Signature records bind identity, meaning, timestamp, values and attachment digests before records are frozen.
EU operations & recoverability
EU-hosted deployment, encrypted off-site backups, scheduled restore drills and controlled release evidence.
INTEROPERABILITY & HANDOVER
Your study data is not trapped in the platform.
Export CDISC ODM 1.3, SDTM, Excel and CSV. Generate a manifest-backed inspection package with study records, audit history, signatures, review status and human-readable casebooks according to the authorised study scope.
- CDISC ODM 1.3Import and export
- SDTMAnalysis-ready handover
- XLSX / CSVOperational review
- Inspection packageManifest + integrity evidence
SEE THE REAL WORKFLOW
Bring one protocol, one CRF or one current data problem.
We will show how the study would be configured, captured, reviewed and exported — and separate standard product capability from any customer-specific validation work.