Clear pathways through the unique challenges of diagnostic development

Diagnostics developers must stare down unique challenges, from managing a multitude of samples and data types to identifying and executing the right regulatory and reimbursement strategies. We can help you face and take down all of them, drawing on our deep experience in in vitro diagnostics and lab-developed tests — including point-of-care diagnostics, molecular diagnostics, immunoassays, and sample collection devices.

We provide expertise across therapeutic areas, with well-chronicled success in oncology, infectious disease, women’s health, and gastrointestinal disorders. Our diagnostics franchise managed the successful premarket approval of the first FDA-approved stool DNA noninvasive colorectal cancer screening test — just one showcase instance of how Premier Research conquers the complexities of developing novel diagnostics.

• Top-tier experience in driving diagnostic development forward. We bring domain expertise for diagnostics of all kinds, tailoring our solutions to support your specific needs at every stage of development. 
• A long and versatile track record with expertise across PMA, 510(k) equivalence, de novo, and dual 510(k)/CLIA submissions. We can answer your regulatory questions, analyze your protocols, and review and support submissions.
• Experience across study settings, including labs, point-of-care facilities, Phase 1 centers, and even subjects’ homes.
• Comprehensive support, from helping you develop and execute clinical trials to providing quality control, regulatory, safety, and compliance solutions.
• Accelerated start-up. Working with a global network of sites, we can often waive the pre-study visit, accelerating timelines and lowering costs.

Comprehensive Diagnostic Solutions