EDC for European IVD performance studies

Faster studies. Safer data. Provable.

AI drafts the eCRF from your protocol, sites capture at the bedside, and data cleans as it arrives — analysis-ready the day you lock.

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Every value, provable.

capturedverified — SDVe-signedfrozen · hashed

Audit-proof by construction — defensible years later

PlatformData integrity

Protocol PDF in, reviewed eCRF draft out — setup in days, not months

ModuleAI study design

SDTM, ODM, Excel and CSV — analysis-ready for statisticians and data science

ModuleExports

Acceptance criteria, method comparison and specimen custody — ISO 20916 by design

PlatformIVD studies

Inside the EDC

Every module, in detail

AI study design — drafts the eCRF from your protocol; a human approves every changeModuleAI Versioned eCRF designer — no-code forms, edit-checks, unlimited log forms; published versions never changeModuleeCRF Query & SDV workflow — only the raiser closes a query; no one approves their own correctionModuleData quality Freeze → sign → lock — signing freezes the record; revocation and unlock leave an audited traceModuleE-signatures Exports — CDISC SDTM, ODM 1.3, Excel and CSV, analysis-ready at any pointModuleData out Audit trail — a database trigger logs every change, append-only and hash-chainedModuleIntegrity Multi-tenant & roles — row-level security isolation, configurable per-study rolesModuleAccess

We are an IVD company and a CRO — we run European performance studies ourselves, and this EDC is the tool we needed. Data integrity, data consistency and disciplined AI are not features here. They are the point.

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Solutions

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Run an IVDR performance study end to end — designed around ISO 20916, from protocol to submission-ready dataset

SolutionIVD manufacturers

Many sponsors, one EDC, zero data bleed — database-enforced isolation and study builds that take days

SolutionCROs

Born from a real PT/INR self-testing study — touch-first online capture, repeat-measurement rules, device traceability

SolutionSelf-testing & POC

Designed to support compliance — GDPR-aligned controls, Part 11-style e-signatures, an ISO 20916-shaped data model. Compliance & security

Perspectives

Integrity the database enforces

Why reliability should not depend on application code behaving — triggers, freezes and one validation engine

PerspectiveData integrity

What changes when the people building the EDC are the same people running IVD studies

PerspectiveWho we are

Three AI surfaces — design, operate, analyze — and the governance line that never moves

PerspectiveAI

See your study, running.

We'll stand up your protocol as a live study — forms, visits, sites, roles — and walk your team from first capture to a signed, exportable casebook.

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