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Genomics Laboratory Testing Quality

Our Genomics Laboratory Testing Quality Management System (QMS) is the cornerstone of our commitment to delivering accurate and reliable data to our clients. We adhere to regulatory requirements, industry standards, and best practices to ensure the highest level of quality in every test we perform.

Overview of quality activities

Our QMS enables continuous organizational and process improvement by incorporating a set of coordinated activities designed to direct and control quality operations. These activities include:
  • Laboratory Quality
  • Process and Document Management
  • Data and Document Retention/Archival
  • Change Management
  • Quality Issue Management
  • Equipment and Facilities Management
  • Training and Competency Management
  • Computerized Systems
  • Vendor Management
  • Audit Management
  • Purchasing and Inventory
  • Customer Service and Customer Feedback Management

Regulatory standards

Our Quality Management System (QMS) is based upon the standards set forth in Good Clinical Practices (GCP), College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA).
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CAP

CAP Accreditation since 2017
CLIA (USA)

CLIA Certified since 2010
CLIA (Edinburgh)

CLIA certified since January 2024
GCP

IQVIA QMS is compliant with the applicable Good Clinical Practices for clinical and genomic testing conducted
NYS (USA only)

NYS certified since 2018

Quality Control (QC) metrics & standards 

To ensure data quality, we monitor several QC metrics and incorporate controls during sample processing. These practices are required as part of our CLIA compliant programs. They are also recommended in voluntary genomic data submissions to the FDA and are recognized best practices. Our efforts promote standardization initiatives including the External RNA Control Consortium (ERCC), MicroArray Quality Control (MAQC) and Sequencing Quality Control (SEQC) Consortiums.
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White paper

Single Cell RNA Profiling of FFPE Tissue

This white paper highlights a study where the objective was to describe and characterize the utilization of single cells prepared from FFPE tissue sections to establish sample requirements, key quality control metrics, and reproducibility of the 10x Genomics Gene Expression Flex workflow.

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Webinar

Beyond One-Size-Fits-All: Mastering analytical testing for today's complex therapeutics

In this informative webinar, industry experts explore the dynamic interplay between cutting-edge technologies and the challenges of modern drug modalities. Viewers will gain insights into how current bioanalytical techniques and technologies are optimizing therapy strategies, where to channel efforts for maximum impact, and finally a roadmap for navigating technical barriers and regulatory challenges in this ever-evolving landscape of drug development. 

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IQVIA Laboratories Genomics is the first to validate Illumina's TruSight Oncology Comprehensive (EU) CE-IVD assay

Our groundbreaking achievements include being the first CRO to validate Illumina's TruSight Oncology Comprehensive (EU) CE-IVD assay, allowing us to offer IVDR-compliant prospective testing of European clinical trial patient tumor samples.

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Article

European Union’s IVDR 2017/746: Impact to Clinical Laboratories and Drug Developers

How central labs can mitigate IVDR impact

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