Having moved to a larger facility in July 2024, hVIVO not only specialises in human challenge trials for vaccine and anti-viral therapeutic development, but now operates as a Phase II/III site for primary care indications as well as housing large containment level 2 and 3 (BSL-2 and BSL-3) laboratories. With the recent acquisition of CRS Clinical Research Services (CRS) and previous acquisition of Venn Life Sciences (Venn), the hVIVO Group has expanded their service offering and is now a full-service early-phase CRO covering a range of indications.
Across the hVIVO Group, there are 5 clinical research and screening units, including a specialised quarantine unit, totalling over 300 beds. In addition, we have recruitment, laboratory, and biobanking facilities. Combined with our data management, biostatistics, pharmacokinetic & statistical analysis, medical writing, and project management services, this consolidated offering allows our clients to work with one company rather than several.
Besides having a vast experience in running early phase clinical trials, our expertise spanning the hVIVO Group encompasses the entire drug development life cycle from discovery/lead optimisation through drug development and lifecycle management. Our combined experience and synergies in chemistry, manufacturing, and control (CMC), non-clinical development, clinical development, and regulatory affairs enables us to deliver on client needs efficiently and cost-effectively.
We have a thorough understanding of running clinical trials, providing expert input on protocol and trial design across a wide range of therapeutic areas.
A unique portfolio of established human challenge models to test a broad range of respiratory & infectious disease products, challenge agent manufacture capabilities, and specialist drug development and consultancy services, enabling you to expedite your drug development and inform on future clinical trials.
CRS is one of the leading CROs in Europe. With over 45 years of experience, these Germany-based units specialise in early-phase clinical trials, including first-in-human, single ascending dose/multiple ascending dose, drug-drug interaction, pharmacokinetic, and proof-of-concept Phase II trials.
Core expertise by indication:
Inpatient and outpatient facilities allow us to run a wide variety of study types:
Phase I & II clinical trials (quarantine & clinical research units)
Recruitment – At hVIVO, we have an active database of >400,000 potential trial participants, across the UK and Germany, allowing us to provide you with the right target population – on time, every time.
Project management – our extensive trial & project management expertise allows us to provide you with the support you need to ensure your trial is performed correctly and in a timely manner
Medical monitoring - Specialist safety oversight at all stages of clinical research with direct access to GCP-certified physicians with extensive Phase I, II & III trial experience
Regulatory affairs – by implementation of well-thought-out regulatory strategies, and by expertly managing submissions and the approval process, we can help you obtain approval for conducting your trial efficiently and in a timely fashion
Data management & biostatistics – we can collect, keep, and use all data in a secure & efficient manner with the help of our experts in the field who have a vast experience within the industry
Medical writing – our team develops a broad range of (regulatory) documents including scientific advice briefing packages, submission documents, clinical trial protocols and reports, informed consent forms, and investigator’s brochures
Quality Assurance (QA) – our QA team provides tailored solutions to meet your QA needs
The laboratory services offered include:
A highly specialized virology and immunology laboratory
Human biological samples
Biosample operations support & biomarker analysis project management
Storage solutions for biological samples and pharmaceutical compounds
We provide a unique blend of consultancy and clinical trial design and execution services, with deep expertise across a broad range of therapeutic areas and all phases of drug development—including CMC, non-clinical, and clinical development.
Venn Life Sciences is an Integrated Drug Development partner offering a unique combination of drug development consultancy, clinical trial design and execution.
CRS is a leading early phase CRO with state-of-the-art research units in Germany, excelling in innovative solutions for early clinical development, from First-in-Human studies to Proof-of-Concept trials in patients.
hLAB is a highly specialised infectious disease and immunology laboratory offering a suite of services to support pre-clinical and drug and vaccine discovery & development.
Through the acquisition of Cryostore™, hLAB have extended their storage offering to the biotech and pharmaceutical industries with locations in London and Cambridge. Crystore™ is a dedicated GxP storage facility for biological and clinical materials in secure temperature-controlled conditions.
FluCamp welcomes participants to take part in our clinical trials under expertly supervised conditions.
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