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.
hLAB specialises in respiratory infection samples obtained from hVIVO. Governed by the Human Tissue Authority, our Biobank houses a diverse range of human biofluids. In addition our ethically approved Research Tissue Bank protocol enables us to prospectively collect samples tailored to your research requirements.
hLAB provides long term storage solutions for biological samples and compounds. Our storage facilities are dedicated GxP (GMP, GDP & GLP) for biological and clinical materials in secure temperature-controlled conditions for the biotech, pharmaceutical and healthcare industries.
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.
Keep up to date with hVIVO's regulatory news by email alerts.
Keep up to date with hVIVO's regulatory news by email alerts.
Keep up to date with hVIVO's regulatory news by email alerts.
Keep up to date with hVIVO's regulatory news by email alerts.
Keep up to date with hVIVO's regulatory news by email alerts.
hVIVO is a publicly traded company on the London Stock Exchange AIM Market under the symbol HVO
hVIVO operates a GCP-compliant Quality Management System (QMS) covering all operational areas involved in the conduct of the clinical trial including clinical, laboratory, project management and data operations. The QA team manages internal audits, service provider (vendor) assessments, SOP control, Quality Incidents tracking, and CAPA oversight. All processes align with ICH-GCP and are designed to meet MHRA, EMA, and FDA regulatory expectations.
Internal audits are scheduled based on risk and conducted across all functional areas. External suppliers are assessed against defined quality standards. Sponsor and regulatory inspections are fully supported.
All controlled documents, including SOPs and study files, are maintained with full version history and access restrictions. Trial Master Files are inspection-ready and undergo QA review. Data handling processes support audit trails, ALCOA+ principles, and system validation requirements.
Quality incidents and CAPA procedures ensure issues are recorded, investigated, and resolved with documented corrective and preventative actions, and follow-up.
All staff receive mandatory training on applicable SOPs, protocols, and regulatory standards. Training records are maintained, reviewed, and updated in line with role requirements and system changes. QA performs regular checks to ensure training compliance across all teams.
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