Question 1

Is this a validated off-the-shelf CliniGA platform?

Accepted Answer

No. CliniGA does not sell a validated commercial platform here. Modular partner technologies are qualified and piloted for a defined intended use, and CliniGA provides the CRO and quality layer around them.

Question 2

Does monitoring alone make a process GxP compliant?

Accepted Answer

No. Monitoring produces data. Compliance depends on procedures, responsibilities, training, deviation and CAPA handling, change control, validation appropriate to the intended use, and documented review of the records.

Question 3

Can third-party sensors or existing systems be integrated?

Accepted Answer

Potentially. Integration is possible only after an interface assessment, change-control review and confirmation of calibration and traceability requirements for each device or system.

Question 4

Can this support international shipping lanes?

Accepted Answer

It depends on the lane. Country availability, mobile roaming and offline behaviour, airline and battery restrictions, GDPR/KVKK and data-transfer requirements, local support coverage and calibration arrangements are checked before a lane is confirmed.

Question 5

How does this relate to CliniGA's site equipment service?

Accepted Answer

The equipment rental and calibration service covers physical equipment and its records. This solution page covers the technology qualification and pilot layer that can sit alongside it when digital monitoring or custody evidence is in scope.

Clinical Trial Technology & Sample Integrity