ICON Releases Flex Advantage to Enhance Patient Randomisation and Clinical Supply Management in Clinical Trials

New technology platform reaffirms ICON as the CRO industry's pre-eminent provider of adaptive clinical trial services

Dublin, Ireland, 19th January, 2015 – ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced Flex Advantage, a next-generation Interactive Response Technology (IRT) platform that offers enhanced randomisation and clinical supply management capabilities and supports the execution of adaptive trials.

Flex Advantage incorporates a host of new features that meet the demands of the most complex protocols. The features include:

  • A flexible randomisation engine that supports adaptive trials – Flex Advantage contains a flexible randomisation engine that can be adjusted mid-study or dynamically, which enables the execution of adaptive clinical trials and more traditional protocol changes. Flex Advantage supports adaptive randomisation trials efficiently, while maintaining trial data integrity throughout.
  • Support for a variety of randomisation methods – Flex Advantage supports various randomisation methods using easy to use plug-and-play modules, allowing for easy configuration to suit the needs of the trial.
  • Support for emergency unblinding – Flex Advantage enables emergency unblinding during the course of a trial and includes additional safeguards that prevent inappropriate sharing of blinded information.
  • Enhanced reporting capabilities – Flex Advantage empowers study teams by providing a full complement of real time web reports that are available via a customisable dashboard. The system's ad hoc reporting capability enables users to quickly and easily create custom reports and also provides drill down functionality to enable users to interact with, and better understand, their study data.
  • Seamless Data Integration – Flex Advantage is integrated with ICON products, such as ADDPLANFirecrest and ICONIK, and external EDC, drug distributor and drug supply forecasting systems, providing study teams with complete visibility of the clinical supply chain, from distributor to patients. Through integration with Firecrest, Flex Advantage enables sponsors and investigators to log into a single ICON portal to capture electronic consent from patients and automatically continue to screen patients within the IRT database.

Commenting on the announcement, Malcolm Burgess, ICON's EVP, Interactive Technologies, said: "Many of our clients are embracing adaptive trial designs to optimise their drug development programmes and these designs can require rapid changes in dosing and drug supply logistics. Flex Advantage not only offers a comprehensive, state of the art drug randomisation and supply management system, it also fully supports the complex logistics involved in executing adaptive trial designs."

Flex Advantage is a component of ICON's ICONIK Informatics Hub which combines industry leading technologies with best practices to help clients to take time and cost from their development programmes.

About ICON plc
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. 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 currently, operates from 77 locations in 38 countries and has approximately 11,700 employees.

Further information is available at www.iconplc.com/innovation

ICON Media Contact

Pippa Chester
Weber Shandwick
+44 (0) 207 067 0190
[email protected]

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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