Your ideal IVD CRO: Agile.
Experienced. Customized solutions.
Every facet of your clinical trials requires flawless execution.
We are the partner who knows how to get it done the right way the first time.
From identification and sample collection to trial execution and results reporting, Precision for Medicine’s in vitro diagnostics contract research organization has you covered. We bring our expertise to every facet of the process—establishing protocols, delivering scientific insights, eliminating hurdles, and ultimately speeding your diagnostic candidate to market.
|•||200+ proven marketing approvals and registrations globally for IVD and companion diagnostics submissions|
|•||150+ years of collective IVD experience in FDA/CDRH/OIR (e.g., Traditional, de novo, and Special 510(k)s, PMAs, IDEs) and FDA/CBER (e.g., 510(k)s, IDEs, BLA)|
|•||End-to-end support from early development through market access and product launch|
|•||Strong relationships with hospitals, laboratories, physicians, institutional review boards, and regulators worldwide|
Precision Clinical Experience
How do you speed an IVD to market?
Find out how we’ve supported other innovators through:
|•||Clinical Validation Studies|
Discover more—download the executive overview.