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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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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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Anatomic and Digital Pathology Services

Integrating Traditional and Digital Pathology to Advance Clinical Development

Home / Central Laboratory Services / Anatomic and Digital Pathology Services

From digitized slide reviews to expert biomarker interpretation, IQVIA Laboratories delivers an integrated approach to anatomic and digital pathology that accelerates clinical development. Our globally harmonized laboratories—spanning the Americas, Europe, and Asia-Pacific—follow standardized SOPs and validated workflows to ensure consistency and reproducibility across trial sites. With 35+ subspecialty pathologists trained in both traditional and digital review, we combine scientific rigor with cutting-edge tools, including custom image analysis powered by AI. Through fully validated, GxP-ready platforms for scanning, remote access, and image management, we offer the flexibility, speed, and insight needed to move from discovery to decision—confidently and at scale.

Digital Pathology Innovation

A Digitized Approach for Faster, More Accurate Decision-Making

With rising demand for precision and speed in clinical trials, IQVIA Laboratories has implemented fully digital pathology workflows across our global labs. Each site is equipped with identical infrastructure and has undergone end-to-end validation to ensure reproducible, regulatory-ready results—whether for exploratory research or registrational non-CDx submission.

Key Capabilities:

  • Image Acquisition
    Epredia 3DHISTECH Pannoramic 250 (bimodal: brightfield and fluorescent) and Leica AT2 (brightfield) scanners
    Standardized file formats: .MRXS and .SVS
  • SlideMaster conversion supports over 90% of file formats and unifies into one file format enhancing flexibility, compatibility, and workflow efficiency.
  • Remote Pathologist Workstations
    Barco medical-grade monitors for high-resolution, color-accurate review
    Configured for in-lab and remote access to keep analysis timelines on track
  • Image Management System
    Proscia Concentriq LS platform for study-specific image repositories, sponsor access, and collaborative case review
  • AI-Powered Image Analysis
    Collaborative Partnerships to utilize foundational models within the field
  • Validation and Compliance
    Full validation per CAP guidelines for IHC and H&E digital interpretation
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AI Driven Image Analysis Ecosystem

Collaborative Partnerships to Accelerate Innovation

In a dynamic landscape without a single dominant image analysis platform, IQVIA Laboratories has built a flexible, best-in-class ecosystem of partners to ensure the right tools are applied to each study. Our “quiver of arrows” approach gives sponsors access to a broad range of validated solutions tailored to unique clinical needs.

 

We work closely with AI innovators, algorithm developers, and image platform providers to support exploratory and regulatory-ready applications—always with our expert pathologists guiding design, validation, and review.

 

Strategic Partnerships

  • Aiforia
  • Biocellvia
  • Flagship Biosciences
  • HistoIndex
  • Lunit
  • MindPeak
  • Nucleai
  • OracleBio
  • PaigeAI
  • PathAI
  • Ultivue
  • Vlsiopharm

Integration Capabilities


Our digital pathology platforms are designed for seamless compatibility with the Proscia Concentriq image management system, allowing for efficient organization, collaboration, and access to study-specific repositories. We support custom algorithm development and validation tailored to each trial’s unique endpoints, ensuring precision and flexibility in image analysis. Built on secure, cloud-based infrastructure (AWS), our solutions enable rapid deployment and remote accessibility across global trial teams.

Anatomic Pathology Services

Proven Anatomic Pathology for Complex Clinical Trials

While digital tools enable greater speed, scalability, and remote access, our roots in anatomic pathology remain essential to the accuracy and integrity of every trial we support. IQVIA Laboratories offers globally harmonized anatomic pathology services that span the full spectrum—from routine histology and immunohistochemistry to complex multiplex IHC and companion diagnostics. With decades of experience and CAP-accredited labs across the Americas, Europe, and Asia-Pacific, our teams are built for scale without compromising on scientific rigor. Each study benefits from customized workflows based on tissue and tumor type, staining protocols, and assay requirements, with direct oversight from our 40 board-certified pathologists representing key subspecialties. Whether supporting exploratory biomarker discovery or regulatory submission, our anatomic pathology capabilities provide the foundation for high-quality data and reliable decision-making across every phase of development.

Advance your research
with proven
anatomic pathology expertise

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• Tissue fixation, processing, embedding, sectioning, and staining.

 

Advanced methods including immunohistochemistry (IHC) and in situ hybridization (ISH).

 

Automated and manual microtomy available depending on study needs.



• Integrated approach supporting co-development, validation, and regulatory submission of CDx assays.

 

Extensive experience in oncology indications with global regulatory alignment.



• 40 pathologists across key subspecialties including dermatopathology, hematopathology, and molecular pathology.

 

Direct involvement in study setup, tissue evaluation, and downstream testing strategy.

Oncology & Biomarker Specialization

Anatomic Pathology Aligned with Your Biomarker Strategy

From PD-L1 scoring to complex multiplex tissue biomarker analysis, our anatomic pathology experts play a critical role in advancing oncology research and beyond. IQVIA Laboratories supports biomarker development strategies that inform patient selection, therapeutic targeting, and trial design—aligned with both clinical endpoints and regulatory requirements. Our pathologists identify and annotate regions of interest, enabling precise downstream testing such as ctDNA extraction, NGS, or molecular profiling. With deep experience in immuno-oncology and combination therapy trials, we also offer robust support for multiplex IHC, allowing multiple markers to be evaluated from minimal tissue. Whether your needs are exploratory or part of a companion diagnostic submission, our AP services are built to deliver high-impact, tissue-based insights at global scale.

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Supporting biomarker development 
  • PD-L1 IHC and other predictive tissue biomarkers
  • Tumor-infiltrating lymphocyte (TIL) evaluation
  • Multiplex IHC development in collaboration with Ultivue for exploratory endpoints
  • Pathologist-guided sample selection for molecular testing, ctDNA, and NGS

Unified Digital + Anatomic Approach

Seamless Integration of Technology and Expertise

Digital innovation doesn’t replace pathology—it enhances it. At IQVIA Laboratories, our pathologist-centric model ensures that human expertise remains at the heart of image interpretation, while digital tools accelerate discovery and drive efficiency.

Advancing Pathology Through Innovation:

  • 2+1 adjudicatory model enabling collaborative review of complex cases
  • Image augmentation for algorithm training across varied stain quality
  • Foundation models built from large, diverse image datasets
  • Ongoing fine-tuning of AI tools to align with clinical endpoints and research goals
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