hVIVO Services Limited is a publicly traded clinical research organisation listed on the London Stock Exchange AIM Market under the ticker symbol HVO. The company is registered in England and Wales (No. 02326557) with its registered office at 40 Bank Street, London E14 5NR. It operates a network of five purpose-built clinical sites across the United Kingdom and Germany.

The company’s current structure reflects a deliberate consolidation of specialist capabilities under a single unified brand. In January 2025, hVIVO completed the acquisition of CRS (Clinical Research Services), a Germany-based clinical pharmacology unit, and subsequently brought its full portfolio of subsidiary businesses — hVIVO, Cryostore, CRS, and Venn Life Sciences — together under the single hVIVO brand. This integration created what the company describes as a fully joined-up early-phase ecosystem spanning consultancy, clinical delivery, laboratories, recruitment, and storage.

hVIVO draws on over 100 years of combined experience across its constituent businesses and has completed more than 1,900 clinical trials. The company holds access to one of the largest specialist volunteer databases in Europe, with approximately 400,000 trial participants on record across its UK (FluCamp) and Germany (Probandeninfo) recruitment platforms. Its client base spans global pharmaceutical companies, emerging biotechs, and CROs at all stages of clinical development.

The company operates Containment Level 3 (CL3) laboratory infrastructure in the UK, enabling it to work with regulated pathogens in the context of human challenge studies. Clinical facilities are located in London and Nottingham in the UK, and Mannheim in Germany.

Key Products and Services

Clinical Trial Services (Phase I–III)

• Clinical pharmacology and Phase I unit services, including first-in-human, single and multiple ascending dose, food effect, drug-drug interaction, and bioequivalence studies
• Phase II/III clinical trial delivery with project management, data management, biostatistics, medical monitoring, and medical writing
• Specialist early-phase study design for healthy volunteer and patient populations across multiple therapeutic areas
• Quality assurance and regulatory affairs support for clinical submissions
• Dedicated recruitment infrastructure via FluCamp (UK) and Probandeninfo (Germany), supporting both healthy volunteer and patient cohort enrolment

Human Challenge Trials

• End-to-end human challenge trial (HCT) services, comprising pathogen production and characterisation, participant screening and recruitment, quarantine unit management, clinical delivery, and sample analytics
• Established challenge models for RSV (respiratory syncytial virus), Influenza A and B, SARS-CoV-2 (COVID-19), Human Rhinovirus (HRV), Human Metapneumovirus (hMPV), Malaria, and Asthma/COPD provocation
• Virus production and characterisation to GMP and regulatory standards for use in challenge studies
• Quarantine and isolation facilities managed to biosafety requirements appropriate for each pathogen

Laboratory Services

• Virology laboratory — viral load quantification, neutralisation assays, and plaque reduction assays
• Immunology laboratory — PBMC processing and isolation, cellular and humoral immune response analysis, flow cytometry, and cytokine profiling
• Molecular laboratory — PCR-based pathogen detection, gene expression analysis, and sequencing
• Microbiology laboratory — culture, identification, and susceptibility testing
• Bioanalysis and characterisation — PK/PD sample analysis, assay development and validation, and clinical trial kit production
• Preclinical PK/PD studies and sample processing network support

Drug Development Consultancy

• Regulatory affairs consultancy — strategy, submission preparation, and agency interactions for EMA, MHRA, and other authorities
• Chemistry, Manufacturing and Controls (CMC) consulting
• Clinical pharmacology, PK/PD, and translational modelling and simulation
• Statistics, study design, and methodology
• Non-clinical development strategy
• Due diligence — independent scientific, clinical, and regulatory assessment for investors and acquirers
• Investor readiness consulting and clinical trials legal services
• Biosample project management and medical writing

Integrated and Accelerator Solutions

• Speed to Clinic Accelerator — packaged service combining consultancy, regulatory, and clinical set-up to reduce time from IND/CTA preparation to first dose
• Integrated clinical trial delivery — end-to-end single-vendor delivery across consultancy, clinical, laboratory, and recruitment
• Translational research consulting and EU expansion strategy advisory
• Human Challenge Model Advantage — strategic advisory for sponsors evaluating HCT as a development tool

Biobank and Storage Solutions

• HTA-licensed cryostorage and biobanking services with multi-temperature storage capability
• 24/7 facility monitoring, full chain-of-custody management, and rapid local access for sponsors and research partners
• Storage of human biological samples and clinical trial materials

hVIVO’s defining differentiator within the CRO landscape is its position as the global leader in human challenge trials — a niche, highly regulated, and operationally demanding methodology that generates early clinical efficacy data in weeks rather than months, at substantially lower cost than conventional field trials. This capability, combined with its CL3 laboratory infrastructure and purpose-built quarantine facilities, is a structural barrier to entry that very few competitors can replicate. The company’s January 2025 acquisition of CRS extended its clinical pharmacology footprint into Germany, adding Phase I unit capacity and a second country of operation in a single transaction. The subsequent brand unification across all group companies signals an intent to present a coherent, integrated offering to sponsors rather than a collection of specialist subsidiaries. For sponsors operating in infectious disease, respiratory, and vaccine development, hVIVO’s combination of challenge models, specialist laboratories, and directly embedded clinical delivery capacity represents a concentrated, single-source development pathway that is difficult to replicate through multi-vendor arrangements. Its AIM listing provides public market visibility and balance sheet transparency, while its large proprietary volunteer database remains a material operational and commercial asset.