CROS NT has extensive experience, both in the U.S. and in Europe, in the area of medical device study design and analysis for regulatory submissions. Our contribution frequently starts prior to the Pre-IDE meeting and culminates in helping the sponsor resolve queries throughout regulatory authority review.
CROS NT is capable of providing services for post-approval studies including statistical sections and sample justification. We understand the changing expectations of the regulatory agencies in terms of data collected so we can produce statistical analyses that meet their expectations.
CROS NT can support in the conduct of medical device trials by:
- Regulatory development plans
- Gap analysis and study design in line with Medical Device Regulation MDR EU 2017/745
- Clinical development plans and protocol design
- Providing expert biostatisticians with a track record of conducting medical device studies, applying the equivalence principle and managing large sample sizes and unique endpoints
- Choosing the right technology solutions for immediate feedback, more accessible trial information and higher data quality
- Measuring uncertainty in medical device trials through an adaptive design approach including safety problems, unexpected treatment effects, high variance and effects in secondary endpoints/subpopulations
- Support and representation for EMA and FDA submissions