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Clinical trials omsbar 3 squares icon

Clinical Evaluation is an essential requirement of every CE marked or FDA assessed product – it is a function of this evaluation to determine whether clinical trials are necessary or whether in-vitro studies, in-vivo studies or studies with healthy volunteers are sufficient to demonstrate clinical validation.

A medical device being pressure tested

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Omsbar works in conjunction with the client and the regulatory authority (normally the MHRA or the FDA) to reach agreement on the need and if appropriate, the protocol and ethics of the clinical trial.

Omsbar constructs clinical trial documentation for medical device and in-vitro diagnostic devices and manages the approval of the trial via the MHRA/FDA and the conduct of the trial – possibly as the Monitor although this role is usually undertaken by the Client.

The clinical liaison is performed in conjunction with contracted Clinical Research Associates if appropriate – the medical device trials environment differs widely from the pharmaceutical environment and care must be taken in both the design and execution of studies to ensure efficient and cost–effective studies.