Oncology Clinical Development ubiquitously uses biomarkers in clinical trials for a range of intended uses. These biomarkers span a range of technologies, require different levels of validation, and ultimately, biomarker data supports submission and approval for the therapeutic. Q2 Solutions, with its vast array of validated assays, is able to support most of these requirements across its global testing laboratory network. Of particular relevance for oncology, Q2 Solutions provides quick turnaround biomarker data to support patient selection for clinical trials and enable targeted investigational therapeutics to be provided to patients. Underpinned by our wide-ranging oncology clinical trial lab expertise, proven methodologies and cutting-edge technologies, Q2 Solutions can effectively support end-to-end oncology-specific testing and assessment needs across Phase I, II and III studies through our global lab network, including:
- Providing key laboratory data for solid tumor, leukemia, lymphoma and multiple myeloma studies worldwide
- Gaining insights on pharmacokinetics/pharmacodynamics, proof of mechanism safety and efficacy and target patient selection
- Supporting large and small molecule, vaccine, cell and gene therapy and biosimilar programs
- Enabling precision medicine through Companion Diagnostics development and related assay validation via CAP and CLIA to ensure use in clinical decision making
- Providing services for investigational use only studies to work toward in vitro diagnostic registration through seamless and long-standing partnerships with leading IVD companies
Q2 Solutions provides assay validation services per intended use and is equipped with a comprehensive assortment of assays that are already validated and ready for clinical trial testing. The principal technologies served are IHC and FISH, genomics, flow cytometry, and circulating protein biomarkers.