Your Partner from Clinical Trial Assays to CDx Development
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.
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- Developing and validating clinical trial assays – compliant to EU and US regulations
- Running clinical performance evaluation studies under IVDR and FDA regulations
- Supporting global regulatory submissions
- Becoming your single-site IVD partner (ssIVD)
Ease your regulatory submission process – Get support from a knowledgeable team!
Our team—with specific regulatory expertise—anticipates solutions to the ever-changing regulatory landscape and prepares you for the rigorous process.
Request your IVD CDx consultation
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.