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 EDC 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 FirsTeck EDC handle GDPR?
Subjects are captured under pseudonymous codes, dates can be minimized at capture, legal basis and consent are recorded on the subject record, and server-generated export receipts record who exported what and when. GDPR compliance still requires the controller's lawful basis, DPIA/RoPA, notices and processor agreements.
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?
Yes. Approved integrations can use time-limited, permission- and study-scoped API credentials. The built-in AI assistant is deliberately separate: it can draft study configuration from approved configuration templates, but cannot read or analyze captured subject data.
Can sites work offline, for example on an iPad at the bedside?
No. Regulated entries require a live connection and explicit server save confirmation. If the network drops, the current screen retains an in-memory retry copy and blocks navigation, but the value is not treated as saved until the server confirms it.
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.