Laboratory Solutions to Support Global COVID-19 Clinical Trials Fact Sheet

Our global network of state-of-the-art laboratories offer Central Laboratories located in Valencia (CA, United States), Edinburgh (United Kingdom), Mumbai (India), Singapore, Beijing (China) and Tokyo (Japan) with partner laboratories in South America and South Africa. Our Centers of Excellence for Vaccines, Genomics and Bioanalytical/ADME are strategically located to offer worldwide testing solutions.

We provide cutting-edge technologies, including detection of SARSCoV-2 virus and antibodies; vaccine neutralization testing; immunologic profiling (flow cytometry and cytokine detection); immunogenicity analysis; bioanalytic techniques for pharmacodynamics and pharmacokinetics and human and SARS-CoV-2 virus genomic analysis. IQVIA Laboratories has the global capacity and high-quality infrastructure to support your COVID-19 clinical trials.

SARS-CoV-2/COVID-19 testing portfolio

Global regulatory readiness for COVID-19 sample handling and testing. Representative laboratory services offered:

SARS-CoV-2 PCR tests	Qualitative to support patient enrollment (inclusion/exclusion) Quantitative to support efficacy endpoint
Serological antibody tests	Qualitative total immunoglobulin (Ig) to support patient enrollment (inclusion/exclusion) Qualitative and quantitative IgM and IgG to identify early versus late infection Quantitative IgM and IgG titers to assess drug off-target effects
Vaccine assays	Immunogenicity: Spike and nucleocapsid antigen specific quantitative ELISA antibody measurement Developing a neutralization assay through a collaboration with University of Texas Medical Branch Partnership with the Coalition for Epidemic Preparedness Innovation (CEPI) to harmonize evaluation of multiple COVID-19 vaccine candidates SARS-CoV-2 specific T-cell response assessment SARS-CoV-2 surrogate neutralization assay, used under license from the Albert Einstein College of Medicine
Cytokine panels	Detection of cytokines including IL-1β, IL-2, IL-4, IL-6, IL-7, IL-10, IFN-γ, GCSF, IP-10, MCP-1, MIP-1α, TNF-α to monitor cytokine storm
Comprehensive portfolio of genomic assays	SARS-CoV-2 complete viral genome sequencing by NGS Host transcriptomic analysis by RNA sequencing and targeted analyses Host genomic analysis by whole exome sequencing and targeted genotyping Host metagenomic analysis by 16S RNA metagenomic sequencing DNA and RNA sequencing Gene expression panels for inflammatory and immune response monitoring
Comprehensive flow cytometry panels utilizing cutting-edge next-generation instruments	T cells: CD3+CD4+CD8-/CD3+CD4-CD8+ ratio, CD3+CD4+IFN-γ+, CD3+CD8+CD38+HLA-DR+, Th, Th1, Th2, Th17, T-Follicular helper, Treg naïve/memory and intracellular staining: IL-2, IL-4, IL-6, IL-17A, IFN-γ GM-CFS, Granulysin, Granzyme B, Perforin, and TNF-α B cells: Plasmablasts, plasma cells – short-lived/long-lived, and memory B cells Monocytes: Blood monocyte shift to inflammatory phenotype Macrophages: Broncho-alveolar lavage Monocyte-derived dendritic cell analysis
Conventional safety markers for prognostic evaluation	Chemistry: Ferritin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), hyper-sensitive troponin I, lactate dehydrogenase (LDH), C-reactive protein (CRP), procalcitonin, albumin Hematology: WBC, neutrophils, lymphocytes and platelets counts Disseminated intravascular coagulation (DIC): Prothrombin time (PT), partial thromboplastin time (aPTT), and D-dimer
Bioanalytical services	Large molecule PK, immunogenicity/anti-drug antibody ligand-binding assays Small molecule PK and drug-drug interaction

Study delivery and logistics

Expedited study set-up
Rapid set-up, flexibility and commitment to support COVID-19 studies
Global kit production and logistics capabilities
Navigating change through robust supply chain infrastructure, flexible kitting solutions and agile logistics support
Near patient collection and local lab data management
Supporting patients and sites with trial continuity solutions including home nurses and phlebotomists
Business continuity
Proactive and coordinated approach in place to minimize impact on our staff and business operations – Read message from our CEO

IQVIA Laboratories is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, IQVIA Laboratories uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.