Assay Validation

Our assay development teams are fast responders, flexible and experienced. We assemble the appropriate team of PhD, MD, and laboratory technicians required to successfully meet your work requirements. Our team becomes an extension of your environment; filling needs and helping meet and accelerate your development timeline.

We have developed more than 150 assays since 1997; for every phase of clinical trial, for companion diagnostics, and for R&D applications (see “Case Studies” below).

For each Validation Study we prepare and deliver a Validation Report to meet your exact requirements. This report includes the method itself and the parameters you require, which typically include:

     Inter and intra assay precision
     Linearity and dilution
     Specificity and sensitivity
     Reportable ranges, and if appropriate, clinical reference ranges

Our development capabilities are supported by a CLIA certified, CAP accredited laboratory capable of processing 10 or 10,000 samples.

Methods and Technologies
We mold to your environment, bringing experience with most assay development methods and technologies including: PCR, ELISA, MSD, RIA, HPLC, cell based assays, IHC, Luminex®, and flow cytometry.

Our technicians average eight years of experience in their platform specializations, assuring your organization of the highest level laboratory work.

Quality Assurance Unit (QAU)
Our QAU remains independent from operations, reporting directly to the president/CEO. Their responsibilities under our GLP-compliant quality system include:

     Document control via QUMAS® ComplianceSP on SharePoint 2010
     electronic document management system (EDMS)
     Training management via UL EduNeering ComplianceWire
     Archive management by the GLP archivist
     Internal quality system and vendor qualification audits
     Critical phase and data/report audits (as applicable)
     Client and regulatory body inspections
     Recommendations to and consultation with operations
     management for continuous improvement and process improvement initiatives
     Regulatory and quality risk minimization

As needed, we offer contract regulatory consulting services to help guide approval and commercialization.

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