IVD Landing Page2018-07-26T10:42:12+00:00

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.

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Diagnostic Development Reinvented:
Comprehensive services from early development through product launch
Please visit precisionformedicine.com to learn more.

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
PMA Preparation
FDA Negotiations

Discover more—download the executive overview.




Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.