Overview

RDI is a contract research organization focused exclusively on the in-vitro diagnostics (IVD) market. It delivers end-to-end clinical development and validation services, guiding clients from regulatory strategy to FDA submission, supported by its own high-complexity CLIA lab and a network of U.S. clinical sites for sample sourcing, testing, and data submission. RDI differentiates itself through its exclusive IVD focus, integration of Diagnostica paperless trial management, and strong quality credentials (CAP accreditation, CLIA certification) to streamline trials and regulatory outcomes. Its goal is to simplify and speed the path to market for diagnostics developers, helping them achieve timely FDA clearance or approval.