We ran the studies first. Then we built the EDC.
FirsTeck is an IVD company and a CRO. This platform exists because the tools we could buy did not understand the studies we run — so every feature answers a problem we have personally had.
Generic EDCs are built by software companies and adapted to studies. This one went the other way: it was built inside a real European IVD performance study — sites, monitors, notified-body expectations and all — by people who design and run such studies for a living.
Domain experience shows up as defaults
- Acceptance criteria and repeat-measurement rules are first-class configuration, because IVD protocols demand them — not an "edit check" you must hand-build.
- Method-comparison statistics live inside the platform, because a performance study's primary endpoint should not wait for an offline SAS run to be inspected.
- Specimen chain of custody, device serials and strip lots are modeled, because that is what the data actually looks like.
- The monitor's day — SDV, queries, risk indicators, site comparisons — is a workflow, not a report bolted on.
Being a CRO keeps us honest
We operate studies on this platform ourselves. When a workflow wastes a coordinator's evening or a monitor's site visit, we feel it before any customer does — and it gets fixed for everyone. That is also why the platform is multi-tenant with database-enforced isolation: we needed to run many sponsors safely before we ever sold a seat.
And when software isn't enough
Because we are a CRO, "the vendor" and "the study team" can be the same people. We design study builds, statistical outputs and vendor interfaces with you — protocol to submission — instead of handing you a login and a manual.