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). 

IQVIA Laboratories has available across its global lab footprint a full spectrum of harmonized assays that supports Clinical Trials for Cardiovascular disease. In addition, our parent company IQVIA has an entire suite of Cardiac services including home cardiac monitoring and 30 minute real time review.

• Lab testing may be broken-down to: 1) Biomarkers of the Risk of Cardiovascular Disease; 2) Biomarkers of active Disease/Damage including myocardial infarction (MI), atrial fibrillation, congestive heart failure (CHF) and 3) Biomarkers of cardiac recovery
• IQVIA Laboratories offers testing for each of these important areas of cardiac disease:
  • For Risk IQVIA Laboratories offers:
    • Full Lipid Panel: Total cholesterol, HDL, LDL, VLDL, LDL particle number, Lp(a), Lp-PLA2, Apo B, CETP (Cholesteryl Ester Transfer Protein)
    • Inflammatory markers associated with Cardiac Rise: hsCRP, sICAM-1, IL-6, IL-18, SSA, MPO, sCD40
    • Additional serum markers: Oxidized LDL, GPX1 Activity, Nitrotyrosine, Homocysteine, Cystatin-C, Natriuretic peptides (BNP, pro-NT-BNP), ADMA, MMP-9, TIMP
    • Genetic Markers including SNPs, DNA Arrays
  • For Active Cardiac Disease/Damage:
    • Troponin-I, Troponin-T, BNP, pro-NT-BNP, CK, CK-MB, Myoglobin, Heart Type Fatty Acid-Binding Protein, cardiac myosin-binding protein C, IGF-1, VEGF (Vascular endothelial growth factor), MMPs (Matrix Metalloproteinases)
  • For Recovery:
    • DAMP (danger-associated molecular pattern) markers: S100A1 and S100A8, Fibronectin, IL-1α, HSP-60 and HSP-70, NF-κB

IQVIA Laboratories has available across its global lab footprint a full spectrum of harmonized assays that supports Clinical Trials for Respiratory Disease.

• IQVIA Laboratories has testing procedures for many of the most severe pulmonary diseases, including:
  • Idiopathic Pulmonary Fibrosis – autoimmune testing, CRP, metalloproteinase (MMP)–7, surfactant protein D (SPD), chemokine ligand (CCL)–18, and Krebs von den Lungen-6 for the purpose of distinguishing IPF from other pulmonary diseases may be useful. In addition, with our IQVIA colleagues centralized review of spirometry, radiographic imaging, and pulmonary function studies
  • Cystic Fibrosis – classic sweet chloride testing, and molecular analysis.
  • Non-specific interstitial pneumonia (NSIP) - Connective tissue disease testing for systemic sclerosis, polymyositis/dermatomyositis, rheumatoid arthritis, and Sjogren syndrome. Hypersensitivity pneumonitis testing and testing for IgG4-related systemic disease.
  • Long COVID – Factor testing of C3, C5a, Bb, IL-6, IL-8, TNF-alpha, and the Terminal Complement Complex (TCC).
  • IQVIA Laboratories also supports studies on: Pulmonary Sarcoidosis, Cryptogenic Organizing Pneumonia, Chronic Obstructive Pulmonary Disease, Acute interstitial pneumonia and Lung Cancer

IQVIA Laboratories in conjunction with our IQVIA Renal Center for Excellence has designed a full array of globally harmonized assays in support of various of kidney diseases, including: acute kidney, disease (AKD) and chronic kidney disease (CKD), Polycystic Kidney Disease Alport Syndrome, Cystinosis, Fabry’s Disease, APOL1- related nephropathy, Diabetic nephropathy, just to list a few. Our Doctors and Scientists are at the forefront of knowledge in renal disease and have presented “white papers,” in this area.

https://labs.iqvia.com/insights/insight-brief-renal-function-clinical-trials

https://www.q2labsolutions.com/blog/the-genesis-of-the-estimated-glomerular-filtration-rate-egfr

• IQVIA Laboratories employs state of the art assays and procedures to support clinical trial investigations in any of these areas. These include:
  • Common Safety testing (CBC and differential and coagulation PT/INR aPTT)
  • Urinalysis, both macroscopic and microscopic
  • Determination of GFR  by numerous methods: including eGFR using the CKD-EPI 2021 calculations and makes available numerous other eGFR such as the Schwartz Bedside for pediatrics; with and without the addition of cystatin-C. . 24 hour urine collection for a measured GFR.
  • Other markers include: β-trace protein (BTP); Neutrophil gelatinase-associated lipocalin (NGAL); Kidney injury molecule 1 (KIM-1); Liver-type fatty acid–binding protein (L-FABP); Asymmetric dimethylarginine (ADMA); Uromodulin; MicroRNA.
  • Genetic analysis is available at our Genomics Laboratory

IQVIA Laboratories has available across its global lab footprint a full spectrum of harmonized assays that supports Clinical Trials for Hematological Diseases. (For Cancer Hematological disease, please refer to the Oncology section).

• Lab Testing for Anemia, Hemophilia and other clotting disorders.
  • Safety testing (CBC and differential)
  • Hemoglobinopathy 
    • Extensive capabilities and expert analysis with consultative capacities
      • Capillary electrophoresis screening
      • HPLC for complex hemoglobulin variants
      • Expert interpretations use electrophoresis/HPLC in context to red cell morphology and indices to provide a complete picture.
      • Molecular genotyping for Hemoglobin A and Hemoglobin B variants is available.Hemoglobinopathy
  • Coagulation (intrinsic and extrinsic pathway analysis deficiencies and inhibitors)
    • Our Coagulation experts guide sponsors and investigators through the complexities of coagulation test from the intricacies of specimen collection through the complex interpretation of results.
    • Assays include
      • Safety assays including PT, aPTT, TCT.
      • Factor assays including Fr VIII and Fr IX
      • Factor inhibition assays by clotting and Nijmegan Modified Bethesda procedures
      • Molecular analysis of various factor mutations
  • Use of Flow cytometry for identification of fetal cells by presence of fetal hemoglobin rather than the insensitive Kleihauer Betke procedure