Question 1

Does the Integration Hub replace CTMS, EDC, eTMF, LIMS or ERP platforms?

Accepted Answer

No. Systems of record remain in place. The hub provides a controlled connector, identity, mapping, workflow, audit and oversight layer around approved interfaces.

Question 2

Can any vendor be connected immediately?

Accepted Answer

No. A connector requires supported interface documentation, data ownership, security and privacy review, mapping, acceptance criteria and a successful bounded pilot.

Question 3

Where are API keys and production secrets stored?

Accepted Answer

Never in the public website or source code. Production credentials belong in an approved secret store with least-privilege access, rotation and environment separation.

Question 4

Which data enters the hub?

Accepted Answer

Only fields required for the documented intended use. Operational metadata is preferred; personal, patient or clinical data requires additional necessity, lawful-basis, privacy and retention controls.

Question 5

How is GxP relevance handled?

Accepted Answer

Applicability is assessed per record and intended use. Validation is risk-based and covers critical mappings, audit evidence, retries, reconciliation, access, change control and continued monitoring.

Clinical Systems Integration Hub | CliniGA OS