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.
Expert support in study setup and data analysis.
Optimising clinical development through expert PK/PD analysis and strategic insight across all phases.
Expert CMC support to ensure safe, consistent, and regulatory-ready drug development from concept to market.
Advancing drug candidates with tailored, expertly managed non-clinical development strategies.
Expert regulatory affairs support for seamless drug development, from submission preparation to ongoing trial compliance and final reporting.
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.
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.
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
The success of drug development programmes depends on the accuracy, readability, and reviewer-friendliness of the documentation. We offer professional medical writing services to assist you in delivering clear and well-structured documents that are fit-for-purpose.
We accommodate both large pharmaceutical companies and small startups offering scalable services – from formatting support to full-scale medical writing. Having a medical writer dedicated to your project will enhance the quality of documents as well as the speed of work and is essential to meeting the targeted timelines.
Our team has vast experience providing documentation for early phase clinical trials such as first-in-human, bioequivalence, drug-drug interaction, and human viral challenge trials.
This documentation includes clinical trial protocols (incl. synopsis and amendments) and (pharmacokinetic) reports, narratives, investigator’s brochures, and informed consent forms.
We can help prepare documentation necessary for interactions with regulatory bodies, such as clinical trial applications or scientific advice meetings.
Safety reporting is an integral part of drug development. Development safety update reports are included in our service offering.
Our team can also facilitate the writing of scientific publications. In addition, we are happy to help develop templates, improve document quality by editing text and formatting documents.
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