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Driving operational improvements and quality of our services

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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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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

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Digital Innovation

Driving operational improvements and quality of our services

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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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Central laboratories

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

Labmatrix® is an industry-leading solution developed to address some of the biggest challenges related to clinical trial sample management.
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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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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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Biosciences

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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Specialty immunoassays

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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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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Insight

Are You Ready for the In Vitro Diagnostics Regulation (IVDR)?

Recommendations on meeting the IVDR
Home / Insights / Are You Ready for the In Vitro Diagnostics Regulation (IVDR)?

Authors: Caroline Freeman, Principal Consultant, IQVIA, Michael Wienholt, Regulatory Director, IQVIA Laboratories, & Alan Wookey, Companion Diagnostics & Oncology Scientific Advisor, IQVIA Laboratories

Regulations around in vitro diagnostic products (IVDs) are designed to assure safety and effectiveness, leading to improved health of patients. The IVD regulation, or IVDR, has led to changes in the way that the European Union regulates IVDs and the challenges these changes pose to manufacturers. While the principles of the requirements will be familiar to manufacturers that already have products on the market, there will be challenges in meeting the IVDR. This white paper reviews recent changes and provides recommendations for actions to be compliant within the timelines. It addresses requirements on companion diagnostics (CDx), and also looks at opportunities to consider when partnering with a global central laboratory for IVD / CDx development.

Complete the form below to access this white paper