Phase I

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.

Human Challenge Trials

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

Phase II–III infectious, respiratory, and cardiometabolic clinical trials across UK and Germany, with expert-led design, rapid recruitment, and advanced diagnostic capabilities.

Clinical Pharmacology

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.

Medical Monitoring

Our experienced, GCP-certified medical monitors provide trusted leadership for externally sponsored trials.

Medical Writing

Accurate, compliant medical writing for clinical, regulatory, and safety documents - tailored to your needs.

Project Management

Expert coordination ensuring timely, high-quality project delivery.

Quality Assurance

Rigorous standards and oversight to ensure compliance and data integrity across all processes.

Recruitment

Reliable clinical trial recruitment with over 400,000 volunteers, advanced CRM technology, and tailored participant matching to accelerate your study success.

Regulatory Affairs

Expert regulatory affairs support for seamless drug development, from submission preparation to ongoing trial compliance and final reporting.

In-patient sites

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.

Out-patient sites

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.

Biometry and Study Design

Expert support in study setup and data analysis.

Clinical

Optimising clinical development through expert PK/PD analysis and strategic insight across all phases.

CMC

Expert CMC support to ensure safe, consistent, and regulatory-ready drug development from concept to market.

Non-clinical

Advancing drug candidates with tailored, expertly managed non-clinical development strategies.

Regulatory

Expert regulatory affairs support for seamless drug development, from submission preparation to ongoing trial compliance and final reporting.

Preclinical Support Services

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.

Sample Processing Network

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.

Laboratory Accreditations

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.

Human Biological Samples

Ethically approved human biological samples from a UK Registered Research tissue bank. Respiratory pathogen-positive sets and prospective collection for advanced research.

Cryostorage Services

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.