Pharmaceutical Development

To support your drug development needs, CirQuest Labs provides tailored panels of biomarkers, and cell-based pre-clinical assays, as well as biomarker testing services across the drug development continuum, from early proof-of-concept to commercial laboratory testing. Whether your drug is in preclinical development, or Phase I - III clinical trials, biologic testing aids in the success rate of any drug development program. CirQuest Labs' scientific staff works with you to identify assays that can be used for preclinical testing and that can be easily transitioned to the clinical trial setting. Testing at CirQuest Labs is performed in compliance with Good Laboratory Practice (GLP) guidelines.

In early drug development, biological testing:

  • describes pharmacodynamic effects, and assists in dosing decisions during trial design;
  • provides potential biologic signatures during early phase clinical trials that may correlate with drug efficacy;
  • yields essential ex vivo tests for drug or subject monitoring;
  • reveals drug off-target effects that may be crucial for identifying new indications and for programmatic decision-making.

During late-stage clinical trials, biologic read-outs may support clinical outcomes, guide future trial design, and support critical in-house decision making. As a result of their proven utility and future promise, biomarkers are increasingly embraced by the medical and regulatory community.

Core laboratory services for drug development:

  • Laboratory and clinical assay development, validation, and testing
  • Protocol review and tailored biomarker sampling based on on-site capabilities
  • User-friendly laboratory manuals and instructional materials
  • Phase I through commercialization on-site and off-site testing, site validation, laboratory training, and monitoring
  • Development and deployment of sample collection and processing kits, central sample receipt, processing, testing and distribution
  • Short-term and long-term biosample storage