Therapeutic Expertise

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. IQVIA Laboratories, 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, IQVIA Laboratories 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, IQVIA Laboratories 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

IQVIA Laboratories 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.

At IQVIA Laboratories, we understand that gastro-intestinal and hepato-biliary disorders often require multi-disciplinary approaches to help successfully navigate related clinical trial lab testing and pathology. Our expert pathologists with both GI and liver subspecialty knowledge and extensive clinical care practice can help guide clinical lab testing strategies and anatomic pathology evaluation across key focuses in these disease areas:

• Inflammatory bowel diseases (ulcerative colitis, Crohn’s)
• Infectious (viral) hepatitis
• Non-alcoholic fatty liver disease
• Non-alcoholic steato-hepatitis
• Neoplastic diseases (hepatocellular and colorectal carcinomas and cholangiocarcinoma)
• Safety testing for hepato-toxicity
• Immuno-oncology testing for GI and liver-specific neoplastic diseases

Leveraging artificial intelligence-driven enhanced image analysis and next-generation technologies, our expert pathologists can dive deeper into complicated histologic disease patterns and extract meaningful data to help understand disease stage and responses to treatment.

From rheumatoid arthritis to multiple sclerosis to systemic lupus erythematosus, IQVIA Laboratories has vast experience in providing clinical trial lab testing to support a range of immunology conditions. With patient safety and efficacy evaluations key, the expert team supports lab assessments from Phase 1 to Phase 3 studies. Our scope of services, include:

• Discovery and translational science assay development services to support assays and testing technologies used downstream.
• Cell-mediated immunity testing through flow cytometry, EliSpot assays, peripheral blood mononuclear cell isolation, etc.
• Humoral immunity assays (i.e., immunoglobulins; complement pathway and a variety of cytokine, chemokine and proinflammatory panels).