Press release
ICON Supports Pfizer and BioNTech on the Investigational COVID-19 Vaccine Trial
Trial capabilities key to enabling agility and speed in global study involving 44,000 subjects DUBLIN--(BUSINESS WIRE)-- ICON plc, (NASDAQ:ICLR), a global
About this update from Icon Plc
[{"type":"text","content":"\nTrial capabilities key to enabling agility and speed in global study involving 44,000 subjects\n\n DUBLIN--(BUSINESS WIRE)--\nICON plc, (NASDAQ:ICLR), a global provider of outsourced drug and device development and commercialisation services to the pharmaceutical, biotechnology and medical device industries and government and public health organisations, today announced it provided clinical trial services to the Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) investigational COVID-19 vaccine programme. Pfizer and BioNTech were the first to announce positive efficacy results from a Phase 3, late-stage study of a COVID-19 vaccine and to receive Emergency Use Authorization in individuals 16 years of age or older from the U.S. Food and Drug Administration.\n\nICON mobilised a large global team of therapeutic and operational specialists to partner on the implementation of Pfizer‘s and BioNTech’s strategic plan and framework for the monitoring of the trial, which included a high level of remote clinical monitoring and source data verification in addition to on-site monitoring, safeguarding data quality and integrity in the evolving pandemic environment. The team combined the benefits of full service and functional service provider clinical operating models to increase efficiency and ensure rapid study start-up.\n\nICON worked with 153 sites in the US, Europe, South Africa and Latin America to ensure the recruitment of more than 44,000 trial participants over a four month period. ICON provided site training, document management and operational support for patient Informed Consent Form review, coordinated eConsent in most countries, and assisted with clinical supply management services. Achieving the unprecedented trial timelines, while maintaining high standards of quality, undertaken in response to the pandemic required collaboration and strong communication between the ICON and companies’ project teams.\n\nSteve Cutler, CEO at ICON plc, commented, “We are proud to have supported Pfizer and BioNTech on one of the largest and most expeditious randomised clinical trials ever conducted, and to have helped accelerate their mission to develop the world’s first safe and effective investigational vaccine for COVID-19. Through close collaboration with Pfizer and BioNTech, we used a full suite of innovative approaches and technologies to su...