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Digital innovation

Driving operational improvements and quality of our services

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Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

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We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

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Corporate Video

Our commitment to customer success is embedded in every facet of our operations.

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Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

 card-3216_Biochemistry expert scientific with eyeglasses
Digital Innovation

Driving operational improvements and quality of our services
WE'RE HIRING

Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

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Download our Corporate brochure

We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

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Discovery Sciences

Our labs bring expertise in protein production, antibody discovery, and immunogenicity to help you select the most promising candidates and reduce risk as you move toward IND-enabling studies.
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Biomarker analysis

a CLIA-certified biomarker testing laboratory developing immunoassays used to quantify protein biomarkers in support of drug mechanism of action, pharmacodynamic, prognostic, and predictive clinical studies across all stages of drug discovery and development.
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Central laboratories

Meeting the demands of today’s drug, device and diagnostics development environment requires a next generation service provider.
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Bioanalytical services

One of the world's largest and most respected bioanalytical and ADME laboratory networks. From our global locations, we serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies worldwide.
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Genomics

We offer a range of genomic laboratory services to support drug discovery, precision medicine and clinical development. Our industry-leading team advances research by delivering scientific insights that help clients maximize the value of their data.
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Vaccines

Combining cutting-edge technology platforms and state-of-the-art laboratories with over 35 years of clinical vaccine development.
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Digital innovation

We have a dedicated Digital Innovation department focused on driving operational improvements and quality of our services. We’ve helped create agile and impactful solutions across the organization with the underpinnings of traceability, productivity, quality, and efficiency.
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Therapeutic expertise
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Therapeutic Expertise

Cell and Gene Therapy (CAGT)

Providing industry-leading science and innovative laboratory solutions across the CAGT spectrum

Expert services to stay ahead of advancing science

The use of alternative treatments such as Cell and Gene Therapies (CAGT) holds great potential for bridging the gaps left by traditional treatments. These innovative CAGT clinical development programs require a suite of complex laboratory assessments to satisfy regulatory submissions and support Proof of Mechanism, Pharmacodynamic, Safety and Efficacy investigations. IQVIA Laboratories with its global laboratory network and industry leading subject matter experts, is ideally positioned to shape, validate, and deliver those biomarker assessments. IQVIA Laboratories can provide flexible, integrated Cell and Gene Therapy development solutions throughout the drug development journey, beginning with the pre-clinical phase and continuing through post-approval.

IQVIA Laboratories offers an extensive array of CAGT laboratory solutions to meet the unique demands of CAGT clinical development
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Industry-Leading Technology and Expertise with a Global Footprint

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Genomics technology

We quickly design and validate potential therapeutics and can accommodate early safety testing with specialized assays, including ddPCR, Next Generation Sequencing and single-cell portfolio.

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Thought leadership

We offer not only laboratory testing but also expertise in the design, validation, and choosing the correct assay for your specific need.

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Global assays

We develop customized assays in our North Carolina laboratory and transfer them seamlessly to Beijing and other laboratories around the world.

CASE STUDY

Winning the successful approval of CAR-T in China

We are connecting across the organization and applying our collective intelligence to solve the most pressing challenges facing CAGT sponsors.

 

In just one example, a CAR-T therapeutic (YESCARTA) was approved by the FDA in 2017. An additional clinical study was set up in China in 2018 and was awarded to IQVIA Laboratories.

 

  • Study title: An Open-Label Clinical Study for Evaluating the Safety and Efficacy of FKC876 in the Treatment of Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
  • Phase 1-2 (bridging study)
  • Enrollment: 15
  • Indications: R/R large B cell lymphoma, including DLBCL, PMBCL, HGBCL, TFL.
  • Primary endpoint: DLT, ORR
  • Secondary endpoint: AE, PFS, DOR, OS
  • Exploratory endpoint: FKC876 expansion and persistence in blood and correlation with efficacy; PD marker and predictive biomarker correlation with efficacy; FKC876 expansion/PD marker correlations with CRS and neurotoxicity; gene mutations correlations with efficacy. 

Category

Biomarkers

Matrix

Method

PK

CD19 CAR-T cell expansion

PBMC

qPCR

ADA

anti-FKC876 antibodies

Serum

ELISA

RCR monitoring

RCR performed on PBMC samples

PBMC

qPCR

Biomarkers

IL6, IL 15, IL1ra, IL2Rα, IFNγ, IL10, IL 8, MCP-1, IL2, GM-CSF, TNFα, IP-10, VCAM-1, Granzyme B

Serum

MSD

CD19, CD20, PD-L1

FFPE

IHC

 

Get in touch

Talk to us about how we can help speed your cell and gene therapies to patients who need them.

Contact us

Related Services

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Central Laboratory Services

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Assay Development Services

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Biomarker Development Services

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Cell and Gene Therapy Solutions

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Clinical Laboratory Services

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Immunoassay Services

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Lab Data Management Solutions

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Central Laboratory PBMC Services

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Pediatric Drug Development Services

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Clinical Laboratories Project Management & Site Support

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Clinical Trial Flow Cytometry Services

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Translational Science and Innovations Laboratory Services (TSAIL)

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Clinical Genomics Laboratory Services

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