Whether in pre-clinical or Phase I - IV clinical trials, biomarker evaluations aid in the success rate of any drug development program. In early drug or device development, biomarkers help identify viable drugs by predicting pharmacodynamic effects, providing potential signatures during early phase clinical trials that may correlate with drug efficacy, provide essential tests for drug or patient monitoring, or in some cases indicate off-target effects. During later stage clinical trials, biomarkers help prove drug safety and effectiveness, guide trial design and support critical decision making. As a result of their proven utility and also future promise, biomarkers are being increasingly embraced by the medical and regulatory community.
To support your drug development needs, CirQuest Labs provides a tailored panel of biomarker assays as well as biomarker testing services (both large and small scale) across the drug development continuum, from early proof of concept to post-approval companion testing:
Clinical assay development, qualification and validation
Phase I through Phase IV testing, site training and instruction, kits, central sample receipt and shipping, short-term and long-term sample storage.
Clinical trial study and PD sub-study support, site validation and training, sub-study kits, central sample receipt and shipping, short-term and long-term sample storage.