CLINICAL
Stillwater MedTech Consulting provides integrated medical and technical assessments and recommendations.
We can help you with complex questions presented by clinical trials and research.
We help clients assess their compliance with FDA requirements relating to subject recruitment, clinical trial advertising and Notices of Availability, reporting, privacy, Good Clinical Practices, informed consent, as well as remunerating healthcare professionals and healthcare entities for research services, and reporting research per the Physician Payments Sunshine Act.
We have experience with:
Clinical Evaluation Report (CER) Writing
Clinical trial strategy to support regulatory pathway
Trial design
Good Clinical Practice Guidelines compliance
FDAAA 801 requirements
Good Publication Practices Guidelines
Notified Body Requirements