- Device trials
- Drug-device combination trials
- All development stages
- All therapeutic areas, providing technical training
- All development stages from FIM to PMCF
Clinical Research Consultants is a dedicated device CRO in terms of study management, but has also gained expertise in document drafting and report writing for the pharma industry, as well as runnig drug-device combination trials governed by the pharma regulations.
We can undertake any stage of development trial, from a first-in-man to a post-market clinical follow-up trial (PMCF/PMS).
We manage all study aspects, directly (initiation, study management, safety management, document development) or indirectly through preferred partners (Data Management and Statistics). We can advise you on the use of paper CRFs or EDC on a case-by-case basis and propose the optimal suppliers.
We currently have ongoing activities in cardiac surgery, interventional cardiology, bone reconstruction, and have previously been active in ophthalmic surgery, endoscopy, urology, gyneacology, and oncology.
Once a proper process is developed and regulations strictly complied with, we strongly believe that application to any clinical research trial is feasible, providing due training on the technology and pathology of that specific trial.
We also believe and have experienced, that the opposite is not true : without a strong knowledge of clinical research processes, GCPs and regulations, even an expert physician can represent a high risk level in runnig a clinical trial, because clinical trial expertise is not an inborn skill, it is an acquired expertise, the result of long years of experience and of a constantly updated learning process.