Laboratory Accreditations

hVIVO accelerates development via Phase I clinics, human challenge models, biometrics, medical monitoring, and Phase II/III sites across UK & Germany. 
Schedule a Call
hVIVO_Lab_Services_BSL_3_infectious diseases
hVIVO is an industry leader in virology and immunology laboratory services, and has been working in this field as a contract research organisation (CRO) since 1989. Operating as a highly specialised virology, immunology and molecular laboratory, our comprehensive array of services are tailored to support drug and vaccine research & development, and drive innovation in the field of virology.

With specialists focusing on virology, immunology and molecular biology, hVIVO is well equipped within our Biosafety Level 2 and 3 facilities to provide high quality sample analysis and data outputs enabling clients to arrive at a proof of concept, or to make a breakthrough discovery in the pathology and possible treatment of diseases with unmet medical needs.
hVIVO_Lab_Services
Our work includes assay development, transfer and optimisation across immunology, molecular and cell-based assays, including offering extensive options in sample matrix and stability testing and analysis. All assays are validated to FDA, EMA and ICH guidelines.

hVIVO is a rapidly growing specialist CRO and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. hVIVO provides end-to-end early clinical development services for our broad and longstanding global client base of biopharma companies.

Key Highlights

70,000+

Number of assays per year

Delivering high-throughput testing capacity to support complex clinical studies with speed, accuracy, and consistency. 

500,000+

Biobank samples

A robust and well-characterised sample repository enabling retrospective analysis and future research opportunities. 

580m²

Lab space

Purpose-built laboratory facilities designed to support a wide range of assays, workflows, and regulatory requirements. 

50+

Lab team

Expert team across virology, immunology, and bioanalysis.

300,000+

Aliquots per year

Precision sample handling and storage processes that maximise sample integrity and traceability across studies. 

85,000+

Samples processed per year

Efficiently handling large sample volumes with rigorous quality control to ensure reliable, reproducible results. 

1,000+

Serology assays per week

Rapid, scalable serological testing to assess immune responses and support vaccine and infectious disease research. 

800+

RT-qPCR samples per week

High-sensitivity molecular testing capabilities for accurate detection and quantification of viral pathogens. 

1000+

Infectivity assay samples per week

Specialist infectivity testing to evaluate viral behaviour and therapeutic efficacy in controlled laboratory environments. 

Meet the Lab Team

hVIVO is led by a dynamic group of experts in their respective fields who are driving excellence throughout the organisation.

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.

 

HVIVO-ACCREDITATION-MHRA

 

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.

 

HVIVO-ACCREDITATION-HTA

 

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. 

 

HVIVO-ACCREDITATION-MHRA

 

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. 

 

HVIVO-ACCREDITATION-CAP

 

UKAS ISO/IEC 17025:2017 Accreditation

HVIVO-ACCREDITATION-HVIVO

 

Partner with hVIVO’s expert Laboratory Teams to deliver high-quality Clinical Data

Speak to our team about your study requirements.

Enquire now

Contact Us