ICON Supports Pfizer and BioNTech on the Investigational COVID-19 Vaccine Trial
04 Janeiro 2021 - 6:15AM
Business Wire
Trial capabilities key to enabling agility
and speed in global study involving 44,000 subjects
ICON 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.
ICON 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.
ICON 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.
Steve 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 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.”
In September 2020, ICON was awarded the Best Clinical Research
Organisation (CRO) at the Vaccine Industry Excellence (ViE) Awards
for the third time. ICON was awarded ViE Best CRO in 2017 and 2014,
and has been named as a finalist every year since 2011,
demonstrating a long history of excellence in vaccine research.
ICON has provided clinical trial services to Pfizer over the
past 30 years and formed a strategic relationship with the company
in 2011, to provide global expertise in the planning, execution,
management and conduct of clinical trials.
About ICON plc ICON plc is a global provider of
outsourced drug and device development and commercialisation
services to pharmaceutical, biotechnology, medical device and
government and public health organisations. The company specialises
in the strategic development, management and analysis of programs
that support clinical development - from compound selection to
Phase I-IV clinical studies. With headquarters in Dublin, Ireland,
ICON employed approximately 15,250 employees in 94 locations in 40
countries as at September 30, 2020. Further information is
available at www.iconplc.com
ICON/ICLR-G
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210104005272/en/
ICON Media Contact Gareth Arnold Weber Shandwick
Telephone: (+44) 07944 688281 GArnold@webershandwick.com
ICON (NASDAQ:ICLR)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024
ICON (NASDAQ:ICLR)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024