We’ve delivered over 250 proven market clearances and approvals, along with numerous favorable coverage and payment decisions for hundreds of diagnostic and medical device solutions—including several game-changing, first-to-market innovations.
Clinical trials for diagnostics and medical devices, regulatory, and clinical utility study design. With a team skill in management of 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. Uniquely, we develop studies to answer the needs of both regulators and payers, creating protocols and CRFs, statistical analysis plans, and informed consent strategies.
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, EU, and rest-of-world 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.
CDx development partner that resolves your complex challenges with elegant solutions. We are powered by strategic science, operating at the intersection of key disciplines with an unsurpassed team of experts that have deep scientific understanding and significant experience in all aspects of companion diagnostics and targeted therapeutic development, registration, and commercialization. From single-analyte tests to complex multi-gene and proteomic signatures, across multiple platforms from immunohistochemistry to next-gen sequencing, Precision for Medicine provides global expertise across the full companion diagnostic development and commercialization continuum.