The regulation of clinical trials across the European Union (EU) will undergo significant changes when the Clinical Trials Regulation (Regulation (EU) No 536/20
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Ethics Approval Granted for Open Orphan’s COVID-19 Human Challenge Study Model
February 17, 2021 GMT
LONDON (BUSINESS WIRE) Feb 17, 2021
Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces the world’s first COVID-19 characterization study has received approval from a specially convened Research Ethics Committee (REC). This news follows the announcement on October 20, 2020 of Open Orphan subsidiary hVIVO’s contract with the UK Government to develop a COVID-19 human challenge study model.
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.
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