The laboratory service business is essential for the growth strategy of Phi Life Sciences. Its goal is to focus on bench to bedside concepts using licensed innovations that allow for a revenue generating R&D growth strategy using leading pharmaceutical, academic, diagnostic, and device manufactures' pre-marketed products. Those products that show clinical relevance will be commercialized through Phi Life Sciences laboratories. The laboratory services portfolio consists of four key service lines: Validation Services. Clinical Trial Services. Clinical Research Specialty Services. Biorepository
Validation services will be run through Phi Life Sciences Good Laboratory Practices (GLP) compliant CLIA laboratory. The focus of this service is to generate data that supports the clinical relevance of innovative molecular diagnostic technologies and devices. Clients that wish to move products through pre-market applications with regulatory bodies such as the FDA, or partner with Phi Life Science's to launch through it's product pipeline will use this service for strategic evaluation. Currently, Phi Life Sciences has 1 validation contract to start in July of 2016.
Clinical Trial Services:
By offering custom molecular diagnostic panels, Phi Life Sciences will be able to work with the specific data needs of manufactures running clinical trials. By using companion diagnostics, cohort screening, and trial developed testing; Phi Life Sciences will offer solutions to manufactures' for their needs that will increase efficacy and safety and improve the overall outcome and success of their Clinical Trial.
Clinical Research Organization (CRO) Specialty Services:
CRO specialty services will focus on the creation and planning of Phase I-IV regulatory submissions, end-point and retrospective studies, and data generation for our CRO partners so that they can submit applications to regulatory bodies for pharmaceutical, diagnostic, and device
Through the creation of a CAP certified bio-repository, Phi Life Sciences will offer specimens that can be used for patient inclusion, exclusion, and stratification for the above services. In conjunction with Phi Life Sciences Validation and Clinical Trial services, the bio-repository services will confirm and substantiate clinical relevance of products.