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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CRS Clinical Research Services, part of hVIVO, is committed to advancing therapies for kidney and liver diseases, including complex conditions where organ impairments impact standard care. Below are examples of the renal and hepatic assessments on offer, combining both standard and specialised methods tailored to each patient’s needs.
Sonography
Fibroscan
Fibrotest
Magnetic resonance imaging (MRI) and computerised tomography (CT) imaging
Child-Pugh classification
MELD (end-stage liver disease) score
Number connection test
Comprehensive liver function tests
Specialised liver laboratory parameters and tests
Estimated glomerular filtration rate (eGFR)
Renal plasma flow rate
Urinary output and electrolyte/creatinine excretion
Body surface area (BSA) adaptations using Mosteller or DuBois formulas
Cystatin C (CysC)
Osmolarity
Iohexol
Pharmacokinetic assessments during dialysis
Since the early 1990s, CRS has been a recognised leader in early-phase clinical trials for patients with renal and hepatic impairments, as well as elderly populations. Based in Germany, CRS operates specialised clinical sites that prioritise participant safety and well-being through close collaboration with local nephrologists, hepatologists, and partner clinics. The team has extensive experience designing and conducting complex pharmacokinetic (PK) and pharmacodynamic (PD) trials, managing intricate protocols involving dose titrations, multiple drug formulations, varied administration routes, and food-drug interactions. Their expertise covers a broad spectrum of conditions, including end-stage renal disease (ESRD), dialysis patients, hepatic insufficiency, metabolic dysfunction-associated steatohepatitis (MASH), and cirrhosis.
Leveraging strong partnerships with hospital departments, CRS accesses specialised facilities such as dialysis units and advanced medical imaging, enabling innovative trial designs that deliver rigorous data and high-quality outcomes, all while maintaining the highest clinical care standards.


With direct access to a network of leading hepatologists, hepatology outpatient clinics, nephrologists, dialysis centers, and other specialist departments at UKSH (University Hospital Schleswig-Holstein), CRS ensures its studies adhere to the highest standards of care while advancing scientific innovation. This extensive network supports the rapid identification and recruitment of suitable study participants, including matched elderly controls, facilitating prompt study start-up and timely trial completion.
CRS also collaborates closely with the accredited medical laboratory Laboratorium für Klinische Forschung GmbH (LKF) to guarantee rapid turnaround of lab results. Combined with in-house blood and urine processing facilities, this partnership streamlines screening procedures and enables real-time safety monitoring across all studies.
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