Whether for patient selection, allocation, or monitoring, CellCarta guides the development and transition of your interventional clinical trial assay to companion diagnostic (CDx) via our ISO13485 framework and regulatory expertise (IVDR knowledge).
With quality systems and a team of regulatory experts, CellCarta provides complete CDx services—from assay development and validation to regulatory submissions, single-site IVD services, and/or transfer to distributed IVD manufacturer.
Our team—with specific regulatory expertise—anticipates solutions to the ever-changing regulatory landscape and prepares you for the rigorous process.
As a global research organization, we prioritize your study goals and clinical trial needs above all else. We aim to provide you with easy, accessible, and comprehensive technologies spanning a multitude of therapeutic areas. Discover our range of services in immunology, histopathology, proteomics, genomics, as well as related ML/AI and sample logistics services.