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 & Characterization Services
Expert bioanalysis and compound characterization for startups, biotech, and pharma. GLP/GCLP-compliant, FDA/EMA aligned services for drug development.
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.
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.
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 operate under GMP and GDP regulations, exceeding industry standards to maintain the integrity and security of your samples. Fully HTA licensed and approved for GMM storage, our facilities are equipped to handle materials up to Biohazard Category 3. A Home Office licence for controlled drugs further ensures secure, compliant storage 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.
hVIVO is a publicly traded company on the London Stock Exchange AIM Market under the symbol HVO
Accelerating drug and vaccine development requires more than great science—it demands strategic planning and regulatory expertise. Our scientific consulting services help you navigate complex challenges in infectious disease, cardiometabolic disorders, and vaccine development. From early-stage design to global regulatory submissions, we provide integrated solutions that reduce risk and speed time-to-market.
• Regulatory strategy and submissions (IND, CTA, NDA) for vaccines, infectious disease, and cardiometabolic therapies
• Scientific consulting for study design and development planning
• Gap analysis and compliance audits aligned with FDA, EMA, and ICH guidelines
• Translational strategy and biomarker guidance for infectious disease and cardiometabolic programs
Scientific and regulatory consulting ensures your development program is optimized for success. By integrating regulatory strategy with scientific insight, we help reduce delays, avoid costly missteps, and improve the likelihood of approval. Our expertise in vaccines, infectious disease, and cardiometabolic conditions positions us as a trusted partner for complex programs.
We align all strategies with global regulatory standards, including FDA, EMA, and ICH guidelines. Our team brings deep experience in regulatory submissions, scientific planning, and translational research to support your program from concept to clinic.
• Reduced risk of regulatory delays and non-compliance
• Expert guidance for complex therapeutic areas including vaccines and infectious disease
• Integrated scientific and regulatory approach for cardiometabolic programs
• Accelerated timelines through strategic planning and modeling
• Consultation & Needs Assessment
• Regulatory Strategy Development
• Scientific Planning & Translational Guidance
• Documentation & Submission Support
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