hVIVO is a full-service early phase CRO.
Specialists in First-in-Human (FiH) clinical trials, CRS delivers fast, EMA-compliant early-phase drug development services with expert subject recruitment, PK/PD analysis, and dose escalation support.
World leading CRO in infectious and respiratory human challenge trials, offering over 14 validated models, state of the art labs & rapid recruitment.
Phase II–III infectious, respiratory, and cardiometabolic clinical trials across UK and Germany, with expert-led design, rapid recruitment, and advanced diagnostic capabilities.
CRS Clinical Research Services, part of the hVIVO Group, delivers end-to-end clinical pharmacology trial solutions with a focus on early-phase development and therapeutic specialisation.
Data Management and Biostatistics
Comprehensive data management and biostatistics support for clinical trials, ensuring accurate data capture, analysis, and timely, high-quality study results.
Our experienced, GCP-certified medical monitors provide trusted leadership for externally sponsored trials.
Accurate, compliant medical writing for clinical, regulatory, and safety documents - tailored to your needs.
Expert coordination ensuring timely, high-quality project delivery.
Rigorous standards and oversight to ensure compliance and data integrity across all processes.
Reliable clinical trial recruitment with over 400,000 volunteers, advanced CRM technology, and tailored participant matching to accelerate your study success.
Expert regulatory affairs support for seamless drug development, from submission preparation to ongoing trial compliance and final reporting.
World-class in-patient clinical trial sites across the UK and Germany, offering over 150 beds for early-phase, infectious disease, and specialist studies including advanced quarantine, PK/PD, and biosafety capabilities.
Five integrated outpatient clinical trial sites across the UK and Germany, offering over 1,000 weekly participant screenings, on-site IMP administration, and advanced laboratory capabilities.
Specialised project management for clinical studies: clinical trial oversight, biosample operations and biomarker analysis management — Good Clinical Practice (GCP)-focused deliveries.
Study Design & Statistical Methodology Services
Expert biostatistics, study design and methodology support across the full drug development lifecycle.
Clinical PK/PD & Pharmacometrics (PK/PD) Services
Expert non-compartmental Analysis (NCA) PK/PD analysis, interim readouts & modelling delivered by 20+ specialists with 25+ years’ experience and GCP-based validated workflows.
Non-Clinical Development Services
Expert nonclinical development support from lead selection to market, including toxicology, PK/TK, ADME and regulatory documentation.
EU & UK Clinical Trials Legal Representation & GDPR Services
Full EU/UK legal representation, GDPR DPR/DPO services, and contract negotiation for sponsors conducting clinical trials.
Expert CMC consulting supporting end-to-end drug substance, product, method and process development for safe, consistent, regulatory-ready products.
Drug Development Due Diligence and Gap Analysis Services
Expert due diligence for investors, pharma and biotechs, with cross‑functional development expertise.
Clear, concise, compliant medical writing for clinical trials and regulatory submissions, including protocols, IBs, PISICFs, CSRs, lay summaries, and CTD modules.
End-to-end regulatory consulting to guide your product through development, interactions with EMA/FDA/MHRA/EU national authorities, and special designations.
Comprehensive preclinical support including drug development planning, PK/PD modeling, translational simulation, and biomarker strategies to accelerate success.
Scientific Consulting & Regulatory Support
Expert scientific and regulatory consulting for vaccine development, infectious disease, and cardiometabolic programs. Strategic planning, compliance audits, and submission support to accelerate success.
Techniques, Technology & Automation
Comprehensive assay platforms including PK/PD, ELISA, ELISpot, RT-qPCR/ddPCR, NGS, microbiome sequencing, and immunoassays. Automated workflows for reproducibility and scalability.
Global sample processing network offering PBMC isolation and downstream analysis for immunology research. GLP/GCP compliant workflows for clinical and translational studies.
Clinical Trial Supplies & Kit Production
Custom clinical trial kits, site training, and investigator support for Phase I–III studies. Bespoke design and RSV stabilization matrix for extended stability.
Bioanalysis & Characterisation Services
Expert bioanalysis and compound characterisation for startups, biotech, and pharma. GLP/GCLP-compliant, FDA/EMA aligned services for drug development.
Assay Development & Validation Services
Expert assay development, customisation and validation for startups, biotech, and pharma. Reliable, fit for purpose from exploratory research through clinical trials.
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.
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Ethically approved human biological samples from a UK Registered Research tissue bank. Respiratory pathogen-positive sets and prospective collection for advanced research.
Secure cryostorage solutions under HTA and Home Office Controlled Drugs licenses with full compliance (GMP, GDP & GLP). Long and short-term storage at Room Temperature, -20oC, -80°C and liquid nitrogen for clinical and research samples including compounds and genome libraries.
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Driving innovation in cardiometabolic research with deep expertise, advanced diagnostics, and end-to-end clinical support.
Accelerating dermatology innovation through expert-led studies, advanced assessments, and rapid patient recruitment.
Driving innovation in infectious disease clinical trials through expert study design, rapid recruitment, and scientifically rigorous execution.
Expertly designed early-phase trials in renal and hepatic impairment to ensure safe, effective therapies for patients with compromised organ function.
Advancing respiratory health through expertly designed trials, specialist assessments, and targeted patient recruitment.
hVIVO is a publicly traded company on the London Stock Exchange AIM Market under the symbol HVO
Our Translational Consulting service bridges discovery‑stage research and regulated clinical development by upgrading exploratory assays, biomarker strategies, and analytical approaches into GLP‑ and GCP‑compliant standards. We support early‑stage biotech and pharma companies in transitioning research‑grade methods into robust, regulator‑ready frameworks.
End‑to‑end biomarker strategy from identification to clinical application
Research assay translation into GLP/GCP‑compliant methods
Deep infectious disease and immunology expertise
Dedicated laboratory R&D team (8 PhDs)
Integrated clinical, analytical, and regulatory capabilities
Early‑stage companies needing translational expertise.
Organisations advancing complex biomarkers or assays requiring robust qualification.
A service supporting the scientific, technical, and regulatory transition from research assays to GLP/GCP‑ready methodologies, enabling confident progression into early‑phase clinical studies.
Yes — we specialise in GLP/GCP translation and validation.
Yes — we evaluate scientific relevance and regulatory acceptability.
Yes — we provide scientifically aligned justification text.
Yes — we integrate PK/PD data to define safe starting doses.
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