Your end-to-end in-vitro diagnostics (IVD) partner

We build a robust evidence base for your intended purpose through structured literature reviews, data synthesis, and documentation aligned to IVDR requirements. The result is credible, well-organized dossiers that streamline your interactions with notified bodies and accelerate regulatory progression.

From precision and reproducibility to sensitivity, specificity, and commutability, we design and execute analytical performance studies that generate regulatory-ready data, de-risking your verification and validation process and giving you earlier go/no-go clarity at every stage.

We leverage our global footprint to run efficient, compliant clinical performance evaluations, coordinating enrollment, testing, data management, and logistics to keep your timelines on track and deliver high-quality clinical evidence faster than a fragmented, multi-vendor approach.

We help you maintain compliance and strengthen your product after launch through ongoing evidence generation, vigilance planning, and scalable lab and data support, so you retain market access and build a continuous improvement cycle grounded in real-world data.

We give you access to routine assays at scale as well as high-complexity testing across oncology, immunology, cardiology, metabolic disease, infectious disease, and more, providing the reliable, consistent data that underpins every phase of your development program.

Draw from our 40,000+ retrospective inventory or design a targeted prospective recruitment program with defined inclusion/exclusion criteria, matrices, and linked clinical data across multiple regions, putting the right samples from the right patients in your hands when you need them.