Clinical Investigations

The certification of a medical device, according to Regulation (EU) 2017/745, is supported by appropriate clinical data that can confirm or demonstrate its safety, performance or efficacy.

There is no one-size-fits-all approach to clinical data collection, but each medical device has its own. A pro-active post-market surveillance plan (PMS) can be conducted in several ways, one of which is by initiating post-market clinical follow-up plans that may involve surveys, in-use tests or clinical investigations.

We provide a full-service or tailor-made service for clinical investigations or post-marketing surveillance. In summary, our approach consists of:

 

• Evaluation of available data: taking into account the intended use and claimed clinical benefits, we perform a preliminary assessment of the available pre-clinical data, the results of risk assessment and, if available, clinical evaluation to properly design the clinical development phases.

• Designing the clinical investigation: We assist in preparing the necessary documentation: Clinical Investigation Plan - CIP, protocol, investigator's dossier, definition of monitoring plans, protocol, choice of sites, definition of population size, survey designs.

• Start: we handle the notification of the necessary documentation to the various approval and control bodies in order to obtain clearance from the legislative authorities in the country where the clinical investigation is conducted.

• Conduction: We follow the initiation of the clinical investigation process, the systematic collection of observations, assist in the communication, where required, of the progress of the clinical investigation and safety information.

• Closure and report of the survey: We verify that all activities to close the clinical investigation have been conducted correctly by performing statistical analysis of the data and producing a report on the clinical investigation.

• Clinical Assessment: The collection of clinical data will require a review of the clinical evaluation including the findings of the clinical investigation conducted, commenting on the results and, based on these, planning new ways of data collection.

Why FTR ADVISOR? Because together with you we design the most suitable clinical data collection pathway for your medical device and your needs.