Open Orphan plc changed its name to hVIVO plc on 26 October 2022, learn more here.
Having a long-lasting experience and expertise in virology and vaccine development, we understand the unique needs of Pharma and Biotech clients and accelerate vaccine development with our fast recruitment capabilities and dedicated resources. Depending on the sample size of your vaccine clinical trial and specific healthy subject population, we can act as a single-site or as one of the sites in multicentre Phase II-III clinical trials.
We have a team of virology and immunology experts, scientists and clinicians on board to support you with the study design, advise on most relevant endpoints and address specific questions related to your unique vaccine candidate. Our regulatory team helps you manage clinical trial application submissions and interactions with competent authorities and regulatory bodies.
One of the core aspects in a highly competitive vaccine development environment is study timelines. We ensure expedited subject recruitment through our specialized volunteer recruitment arm, FluCamp. With extensive healthy volunteer database of over 250k, enormous screening capacities of around 1k subjects/week, decades of experience attracting suitable healthy subjects via multichannel approach and tech-enabled platform, we meet your recruitment requirements and timelines with each and every study we conduct.
Our specialized laboratory hLAB offers a suite of services to support clinical vaccine development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
Therapeutically focused commercial site
Experienced scientific and clinical teams
Thorough experience in vaccine trials
Dedicated healthy volunteer recruitment
Healthy volunteer database
Specialized on-site virology immunology lab
Our team develops a broad range of regulatory documents: from Scientific Advice briefing packages over IND submission documents to clinical study reports
hVIVO’s extensive expertise in human challenge trials and vaccine trials allows the company to provide you with the support and management you need to ensure your trial is performed correctly and in a timely manner
Our statistics, study design and methodology services are available to optimise the design of your trial
hVIVO can enhance the quality of your trials through accurate identification & selection
We can collect, keep and use all data in a secure & efficiently manner from the help of our experts in the field with vast experience within the industry.