eCRF, EDC, IVDR — the questions we actually get.
Short, factual answers. For a live demonstration of any of them, request a demo.
What is an eCRF, and how is it different from an EDC?
An eCRF (electronic Case Report Form) is the structured form a site fills in for each subject; an EDC (Electronic Data Capture) system is the platform that builds, hosts, validates, and audits those forms across a study. FirsTeck EDC is the platform; the eCRF is what it delivers.
Is FirsTeck built for IVDR performance studies?
Yes. It captures analytical and clinical performance data with built-in acceptance criteria and repeatability checks, computes method-comparison statistics (bias, Bland–Altman limits of agreement, robust regression) and qualitative agreement (PPA/NPA/OPA), and tracks specimen chain of custody — the substance of an ISO 20916 / IVDR Annex XIII performance evaluation.
Does it support 21 CFR Part 11 and EU Annex 11?
It provides the technical controls those rules call for: e-signatures with password re-authentication and a bound content hash, an append-only audit trail enforced in the database, and record-level freeze on signed data. Compliance itself is achieved by your validated deployment and your procedures — the software supplies the controls, not a certificate.
How does it handle GDPR?
Subjects are captured under pseudonymous codes, dates can be minimized at capture (e.g. year-only birth dates), legal basis and consent are recorded on the subject record, and every export is logged — who exported what, and when. Optional blockchain anchoring sends only cryptographic hashes, never personal data.
How do I get data out for analysis and submission?
Export real Excel workbooks, CSV, CDISC SDTM-style domain datasets, CDISC ODM XML, method-comparison results, and print-ready PDF casebooks — at any point in the study, scoped to your role and sites. Explicitly-missing values keep their coded reason, so downstream analysis distinguishes “not done” from “not entered”.
Can it integrate with our other systems — or with AI analysis?
Yes. A permission-scoped REST API and an agent interface (MCP) expose the same data the UI shows — nothing more. Connect an AI analyst such as Claude to pull the complete dataset and draft analysis reports, or name your vendor systems (LIMS, safety database, statistics platform) and we design and build the interface with you.
What is blockchain anchoring, and do I need it?
An optional integrity add-on: cryptographic hashes of records and signatures are periodically anchored to a public blockchain, so an independent party can later prove the data existed unchanged at that time. Only hashes leave the system — no subject data — which keeps it GDPR-safe. Most studies are fully served by the built-in append-only audit trail; anchoring is there when your audit programme demands third-party proof.
Can sites work offline, for example on an iPad at the bedside?
Yes. The capture app is built for the bedside iPad: entries save automatically, keep working through network drops, and sync when the connection returns. Nothing typed is lost.
Ask with your protocol in hand.
The fastest way to evaluate an EDC is to see your own study running in it. We set that up for you.