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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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Science Innovation

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

Learn more
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Digital Innovation

Driving operational improvements and quality of our services

Learn more
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Services

Bioanalytical and ADME Laboratory Services

Accelerate and enhance discovery, preclinical and clinical programs

IQVIA Laboratories bioanalytical solutions for your most complex challenges

As increasing regulatory and scientific complexities threaten R&D productivity, you need a bioanalytical and ADME partner who can truly enhance the drug development process. 

IQVIA Laboratories offers complete bioanalytical and ADME laboratory services for testing around the globe and across the product development spectrum. We combine knowledge from the collective services provided by our central labs and bioanalytical and ADME laboratories. The result is timely, high-quality, regulatory compliant data that supplies the insights you need to make more informed decisions and instill confidence in your regulatory filings.

Our bioanalytical laboratory services include:

Liquid chromatography–mass spectrometry (LC-MS) and hybrid LC-MS services

For the quantitative determination of small molecule, peptide and macromolecule therapeutics in support of pharmacokinetic (PK) studies.

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In vitro ADME assays and metabolite identification services

Including permeability, metabolic stability, metabolite identification (cold & radiolabeled), and in vitro drug-drug interaction risk assessment, ranging from highly automated discovery screening platforms to definitive development studies that enable regulatory submission.

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Immunoassay services

Including quantitative determination of large molecule therapeutics using ligand binding assays technologies in support of pharmacokinetic (PK) studies and immunogenicity assays assessments for pre-clinical and clinical studies including tier based approaches, neutralizing assays, and isotyping assays.

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Fit-for-purpose biomarker services

Including quantitative determination of large molecule therapeutics using ligand binding assays technologies in support of pharmacokinetic (PK) studies and immunogenicity assays assessments for pre-clinical and clinical studies including tier based approaches, neutralizing assays, and isotyping assays.

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Advanced Techniques

We are one of the few bioanalytical laboratories successfully employing immunocapture, multidimensional (up to 3-D) liquid chromatography (LC) and high-resolution mass spectrometry (HRMS) for biological analyte LC/MS quantitation. We have an industry leading reputation in dried-blood spot (DBS) and dried-plasma spot (DPS) microsampling, and are one of the few service labs with experience in utilizing the HμREL® co-culture model to predict clearance and assess metabolic profiles of low turnover compounds.

Customer focus

We excel at employing innovative processes and finding custom solutions for our customers including scheduling flexibility and tailored project management support based on your project’s specific requirements. We know the importance of your deadlines and are willing to commit resources to meet your goals and timelines so you can keep your product on target.

Global Footprint

We serve many of the largest pharmaceutical, specialty pharmaceutical and biotechnology companies in North America, South America, Europe and Asia with scalable expertise and innovative solutions.

 

Location

Services

Indianapolis, IN, USA
  • Home to our Center of Excellence for automated in vitro ADME screening, discovery LC-MS/MS bioanalytical, in vitro metabolism, and metabolite identification capabilities
  • Industry-experienced scientists and 24,000 square feet of lab space
  • Also available:
    • GLP compliant bioanalytical liquid chromatography mass spectrometry (LC-MS) laboratory
    •  Bioanalytical and immunogenicity (ADA and NAb) laboratory
Ithaca, NY, USA
  • GLP compliant bioanalytical liquid chromatography mass spectrometry (LC-MS) laboratory
  • LC-MS biomarker assays in support of PK/PD studies
  • HRMS, Nano-flow chromatography and Immunoanalytical/LC-MS hybrid assays
  • TK and PK studies
RTP, NC, USA
  • Bioanalytical and immunogenicity (ADA and NAb) laboratory
  • Discovery bioanalytical/lingand binding assays - biologics and biosimilars
  • Bioanalytical ligand binding PK laboratory
  • Immunogenicity ADA and NAb laboratory
  • Ligand binding biomaker assays in support of PK/PD studies
Beijing, China
  • GLP compliant bioanalytical LC-MS laboratory
  • CAP certified for LC-MS biomarker assays in support of PK/PD studies
  • Immunoassay (PK and immunogenicity) capabilities

 

We not only have the technology, systems, and processes to support your routine and complex projects, but we have 30+ years of experience and industry leading knowledge to provide key insights into the development of your product.  

We can also help you develop methods for detecting your small and large molecule therapeutics, and to provide industry leading assays for immunogenicity assessments. The result is reliable, high-quality data for better decision-making, faster, more efficient drug development, and higher quality regulatory submissions.

30+ years of bioanalytical experience.

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