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
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.