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