We’ve delivered over 250 proven market clearances and approvals, along with numerous favorable coverage and payment decisions for hundreds of diagnostic products—including several game-changing, first-to-market innovations.
Clinical trials for diagnostics and medical devices. With a team solely dedicated to diagnostic and device trials, we identify sites, recruit investigators, and maintain all regulatory documentation. We then manage and monitor the study and collect the data in compliance with all GxP regulations needed for both regulatory approval and payer negotiations.
Regulatory strategy development and execution. Our regulatory experts offer comprehensive to-market regulatory and evidence development strategies, anticipating areas of regulatory risk and monitoring developments in a shifting policy landscape. We handle every facet of regulatory approval, from ISO and CLIA certification to authoring FDA/EMA submissions, helping you manage regulatory risk and accelerating time to market.
Market access, clinical utility, and evidence strategies. We understand the codes, the fee schedules, the coverage processes, and the evidence that payers need. And we know the most effective ways to weave them together, so when you go to market you get maximum access in minimum time.
Regulatory and clinical utility study design. Uniquely, we develop studies to answer the needs of both regulators and payers, creating protocols and CRFs, statistical analysis plans, and informed consent strategies.