You have successfuly obtained the market clearances of your products and/or the ISO certification.
You are wanting to define your post-market clinical follow-up and assess the clinical efficacy of your products on the long-term.
We can assist you in :
Clinical protocols and clinical studies
Most of junior companies obtain market clearances on the first try, without clinical data (in the case of 510k) or with a simple literature research report (CE mark).
Things can get worse with clinical data as companies have to prove clinical efficacy of their products in their sales arguments.
We can help you in this critical phase where clinical data shouldn't be put aside.
On top of this, an increasing percentage of clinical research requires medical imaging as part of the screening, safety and/or efficacy evaluations. The more critical the outcomes of the image reviews are, the more important it gets to involve specialists.
A specialist can drive consistency, avoid regulatory criticism about review bias and maximize the statistical weight of the acquired imaging data. Our experts can guide a biotech/pharma company through image management challenges.
MD101 has consultants available who can support various levels of trial image management. This includes independent advice about imaging protocols, image reading, imaging CRO selection and iCRO expectation management. Services can be combined with image project management and image dedicated site/CRA (Clinical Research Associates) training.
As a result, not only the imaging budget might be decreased, but also it will help to set-up international compliance and operational effectiveness while collecting the valuable imaging data.
The radiologic imaging expertise reaches from medical devices to IP trials, with indications in MSK (musculoskeletal), oncology, neuroscience, cardio-vascular disease and others.