Scoping the clinical evaluation
The specific regulatory requirements to be addressed as well as the relevant clinical research question(s) need to be identified in a Clinical Evaluation plan or strategy.
From there a review of existing clinical data is performed to establish if additional clinical data need to be generated to address the clinical research questions through the gathering of new clinical data (i.e., a clinical investigation).
Qserve has experts (many of whom were former regulators) who are very familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfill the regulatory requirements.
The evaluation of existing clinical data regarding a medical device is essential in understanding the benefit and risk determination of a medical device. Clinical literature- and safety data available in the public domain are assessed and reported on.
Review of clinical literature data is key estimate baseline risk associated with the device, and to identify potential knowledge gaps that will need to be addressed during the Clinical Evaluation, possibly including clinical investigation of a medical device.
Qserve has a dedicated staff with key competences in setting the objectives and scope for a literature review. In case there are no gaps the Clinical Evaluation can be completed based on existing clinical data only and no additional clinical data is necessary.
If the Clinical Evaluation Strategy identifies the need to collect new (additional) clinical data, Qserve can continue to perform the clinical investigation on behalf of the manufacturer.