ICON, provider of outsourced drug and device development and commercialisation services to the pharmaceutical, biotechnology and medical device industries and government and public health organisations, has announced it provided clinical trial services to the Pfizer and BioNTech investigational COVID-19 vaccine programme. Pfizer and BioNTech announced positive efficacy results from a Phase III, late-stage study of a COVID-19 vaccine and to receive Emergency Use Authorization in individuals 16 years of age or older from the US Food and Drug Administration.
ICON used a global team of therapeutic and operational specialists to partner on the implementation of Pfizer‘s and BioNTech’s strategic plan and framework for 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 company 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. It 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.
Steve Cutler, CEO at ICON, 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 support achieving fast site activation, patient recruitment and remote and on-site monitoring, which enabled us to meet accelerated study timelines on the way to delivering high quality data for regulatory approval. I’d like to thank all of the study team members from Pfizer, BioNTech and ICON who collaborated so well. This trial has demonstrated the benefits of a strong sponsor/Clinical Research Organisation partnership and has redefined industry expectations in terms of trial management and speed, while never compromising safety, quality and integrity. We look forward to applying the experience gained over the past year to future trials.”
Image credit: Markus Spiske
