CRO Services

A Clinical Research Organization to Outsource All of Your Research Needs.
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Our Services

CLIA Certified for medium and high-complexity testing and ISO 13485 Medical Device QMS Certified allowing us to provide a range of valuable contract services including:

                  • Study Design
                  • Protocol Development
                  • Clinical Validation
                  • Analytical Validation
                  • Reference Lab Testing
                  • IRB Approval Process
              • Clinical Trial Site Mgmt
              • Decentralized Site Mgmt
              • Data Management
              • Project Management
              • Medical Affairs
              • Regulatory Submissions
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                  • FDA 510k Studies
                  • FDA EUA Studies
                  • De Novo Studies
                  • PMA Studies
                  • ED IVD Pre-submissions

Our Capabilities

01

ANALYTICAL STUDIES

EQUIPMENT & ASSAY VALIDATIONS

        • Multiple Analytes
        • ELISA Single Analyte
        • Lateral Flow
        • PCR/CRISPR

IMMUNOASSAY VERIFICATIONS

        • Accuracy, Precision, Linearity
        • Interference & Cross-Reactivity
        • Stability
        • Limit of Detection

IMMUNOASSAY VALIDATIONS

        • For FDA Submission
        • For CE-IVD Submission
        • For Lab Developed Tests (LDTs)
        • For Research Use Only (RUO)

02

MULTIPLEX ASSAY

        • High-throughput, automated liquid handling TECAN EVO 150
        • High-throughput, CE-IVD protein multiplex reader Luminex (R) FLEXMAP
        • R&D protein multiplex reader Luminex (R) MagPIX
        • R&D protein multiplex reader Quansys QVIEW
        • Custom Equipment & Assay Onboarding

03

PCR & NAT

Applied Biosystems 7500 Fast DX Real-time PCR System
Applied Biosystems MiniAmp Thermocycler
Ubiquitome Liberty 16
NUCLISENS easyMAG
Roche Cobas 6800

We work for you!

Our services are tailored to meet your needs.

Contract research services for in vitro diagnostics, companion diagnostics, biologic discovery, liquid biopsy, cancer monitoring, clinical trials, and research use. We specialize in customization to meet the unique needs of our client. 

  Our Sites & Collections

We have the regulatory, clinical and analytical resources needed to complete studies for FDA and EU submissions, and the certifications and experience necessary to collect samples quickly across the United States and Europe.

Completed Studies

Samples Collected

Partnered Clinical Sites

Patients Tested & Resulted