ICON'S Firecrest Training Recognized by TransCelerate BioPharma Inc.


Company News Release

Firecrest platform offers unique capabilities for improving the quality, consistency, and compliance of ICH/GCP

ICON plc, (NASDAQ: ICLR) a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its Firecrest training meets TransCelerate BioPharma Inc.’s minimum criteria for International Conference on Harmonisation Good Clinical Practice (ICH/GCP) training.

TransCelerate-certified GCP training enables investigators to complete GCP training that is mutually acceptable by all TransCelerate member companies. Investigators completing the training will avoid having to repeatedly complete pre-qualification GCP training for every trial and can instead focus on study-specific activities that accelerate the delivery of therapies to patients.

ICON’s Firecrest GCP training offers some unique capabilities that are currently unavailable in other GCP training programmes. Sponsors can assign training requirements per specific job role, track training compliance and notify users of overdue training or re-certification due dates. In addition, the programme offers enhanced reporting capabilities that allow biopharma companies to analyse and report completion metrics at a region, site or role level.

Commenting on the announcement, Dr. Steve Cutler, Chief Operating Officer, ICON plc, said: “ICON’s Firecrest technology platform delivers an innovative suite of training, performance support and study management tools which have proven to enhance the compliance, consistency and execution of study-related activities by study personnel. We are pleased that the TransCelerate member companies recognise that our Firecrest GCP training module reflects their best practices for training.”

TransCelerate BioPharma Inc. is a non-profit organisation dedicated to accelerating and simplifying the research and development of innovative new therapies. The organisations' mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritise, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc., Forest Research Institute, Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.


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