Accelerate your
clinical development.
Draft your eCRF from the protocol with AI, build it without code, and capture at the bedside — online or offline. Every value still keeps its full provenance and stays provable to a regulator years later.
Capture it. Verify it. Prove it.
Sites enter data; monitors and data managers review it; an inspector may one day ask you to defend it. The same record has to answer all three — so the system, not the paperwork, keeps them honest.
Enter data where care happens
A designer-built eCRF that validates as you type and keeps working when the network doesn't.
- Offline-capable; edits are never lost
- Server-authoritative validation
- Per-study, per-site access
Review with duties kept apart
Source-data verification, queries, and DM/CRA review — separation of duties enforced by the system.
- Field & form SDV, risk-based monitoring
- Editing a value voids its verification
- The reviewer can't be the editor
Defend every value, later
An append-only trail and a frozen, hashed signature make the record independently verifiable.
- Immutable, trigger-backed audit log
- Part 11 e-signature with re-auth
- SDTM / CSV / PDF casebook export
Everything a trial runs on.
Tenants can't see each other. The database enforces it.
Isolation shouldn't rest on remembering a WHERE clause. Every request runs as a constrained role inside a per-tenant transaction, so row-level security applies to reads and writes alike — even raw queries.
- Row-level security, not app trust
- The app connects as a non-owner role; each query is bound by the tenant set on the request. A connection with no tenant context reads nothing.
- Append-only audit engine
- A database trigger writes an immutable row for every insert, update, and delete — and auto-attaches to any new table, so coverage can't drift.
- Signed records are frozen
- Once a form is e-signed, a trigger blocks further change at the database level — the freeze doesn't depend on application code behaving.
Draft from the protocol. Run it from your tools.
Hand the assistant a protocol PDF and it drafts the CRFs, visit schedule, and consent bindings for your data manager to review and approve — never applied blindly. Your model key stays encrypted and tenant-scoped.
Prefer the terminal? Issue an API token and drive the EDC from an agent over MCP — same permissions, same row-level security, same audit trail. Signing and token minting stay human-only.
# authenticated by an issued token — acts as your user $ edc subjects --study 2025HZ001 --site GE-GAL A005 enrolled 88% A006 enrolled 100% e-signed A007 screening 41% 1 query $ edc query open A007 --field temp \ --text "Confirm 38.4 °C — outside range" ✓ query #1180 opened ↳ recorded in audit_log, attributed to you
Inspection-readiness, wired in.
Not a checklist on a slide — controls built into the system, each one demonstrable in the running product.
eCRF, EDC, and IVDR — the basics.
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, Passing–Bablok) 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 do I get data out for analysis and submission?
Export flat CSV, SDTM-style domain datasets, method-comparison results, and print-ready PDF casebooks — at any point in the study, scoped to your role and sites.
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.