Open Orphan plc changed its name to hVIVO plc on 26 October 2022, learn more here.
Building on decades of unrivalled experience, hVIVO is currently the only CRO focused on challenge studies, providing world class expertise and capabilities in challenge agent manufacture, a unique portfolio of established human challenge models to test a broad range of infectious and respiratory disease products, and specialist drug development and clinical consultancy services.
(Wuhan, Delta, Omicron)
Generates invaluable dosing, safety and efficacy data
Helps optimise for larger field trials
Requires fewer subjects
Significant time savings
De-risk Phase III program
Potential for Fast Track or Break Through designation
Potential approval and Emergency Use Authorisation
Significant valuation uplift for Biotech sponsor
Allows products to "Succeed fast" or "Fail Fast"
At hVIVO, we prioritize the safety and well-being of our participants throughout the hMPV challenge studies. We strictly adhere to robust ethical guidelines and regulatory standards to ensure all protocols are ethically sound and meet the highest safety requirements. Our experienced team of scientists, physicians, and support staff are dedicated to maintaining the utmost professionalism and care for all participants involved.
Our Human Challenge Trials are an ideal tool to provide early efficacy data for your vaccine and drugs in infectious diseases
Our drug development consultancy services support the development of your product throughout the lifecycle
Discover our study design & methodology services to optimalise the design of your trial
Discover our offering to support your phase 1 & phase 2 clinical trials
Our dedicated recruitment team offers tailormade trial recruitment solutions and has a wealth of experience in recruiting special populations
Out London site has all the assets to be part of your multi-center patient trial
Our data management & statistics solutions offer you a quick and efficient biometric solutions for your clinical trial
A broad suite of services to support non-clinical and clinical respiratory drug and vaccine discovery and development
Our team develops a broad range of regulatory documents: from Scientific Advice briefing packages over IND submission documents to clinical study reports