Laboratory Outsourcing Is Getting Harder to Get Right. Is Your Team Ahead of It?

Sample volumes are rising. Regulatory scrutiny is tightening. Infectious disease and immunology endpoints are demanding more specialist input than ever before. Inside this guide, we walk you through what that means for your development programme.
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Specialty laboratory outsourcing looks straightforward. It rarely is.

Every year, promising development programmes lose time, not because the science was wrong, but because the laboratory partner couldn't keep pace with the complexity of the study. Getting this right takes more than a list of assays. It takes integrated scientific expertise, validated platforms, and a team that has navigated these challenges before. Today's sponsors are working through:

  • Infectious disease and immunology endpoints that demand specialist, not generalist, testing
  • Multi-site studies where sample integrity depends on robust chain-of-custody, not good intentions
  • Assay validation and technology transfer timelines that can challenge their development plan
  • Regulatory expectations that require GCLP and ISO-accredited data, not just "compliant" data
  • Biospecimen and drug product storage requirements that are easy to underestimate until they fail
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hVIVO Delivers for Lab Clients

This guide outlines hVIVO's laboratory capabilities and standards that will facilitate what you do best - getting on with your study.

One brochure. Every laboratory discipline you need to evaluate.

Scientific Leadership

Decades of expertise in virology, immunology, and translational science, helping you choose the right assays for your study.

Diverse Technology Platforms

Flexible, scalable molecular and biomarker analysis tailored to your pipeline's research, clinical, and commercial milestones.

Clinical Co-location

State-of-the-art laboratories embedded within our clinical and recruitment facility, accelerating timelines and reducing friction.

Ethical Oversight and Compliance

Strict regulatory and GCLP/GxP compliance checks safeguard sample integrity at every stage.

Ready to Scale With You

A flat structure and experienced project team take you from discovery assays through to GxP-validated assays for clinical trials.

End-to-End Solutions

From regulatory consultation to assay development, translational research, and high-volume bioanalysis and sample storage.

Continuous Investment

We invest in new technologies as they emerge, keeping pace with evolving sponsor requirements.

Built by the team behind hVIVO's laboratory science programme.

The expertise in this guide is grounded in hVIVO's infectious disease and immunology heritage. We lead hVIVO's laboratory services, supported by a team of specialist scientists working across virology, molecular biology, immunology, and microbiology. hVIVO operates purpose-built BSL-2 and BSL-3 laboratories supporting biotech, pharmaceutical, and CRO sponsors from pre-clinical research through to Phase III.

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Andrew Catchpole

Chief Scientific Officer

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Alex Mann

Director, Clinical Science

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Chris Forsdyke

Head of Laboratories

Martin-Larke
Martin Larke

Principal Biostatistician

Our Accreditations

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard; for designing, conducting, recording and reporting trials. Ensuring participant safety prevails over the interests of science and society.

 

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Human Tissue Authority (HTA)

hVIVO is accredited by the Human Tissue Authority (HTA), meaning that we have been recognized by the HTA as compliant with standards and regulations for the ethical and legal removal, storage, and use of human tissue. A HTA license is essential, as hVIVO handles human tissue for various research purposes.

 

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Good Clinical Laboratory Practice (GCLP)

All clinical trials comply with GCP and/or GCP for Laboratories (GCLP) guidance. Human Challenge Agent-only clinical studies that do not involve IMP also comply with GCP/GCLP. 

 

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College of American Pathologists (CAP)

The CAP laboratory accreditation programme ultimately recognises laboratory quality and compliance. CAP accreditation is globally recognised, and provides assurance the hVIVO laboratory services are able to be delivered to a standard. 

 

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UKAS ISO/IEC 17025:2017 Accreditation

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