News Release

Software provides an integrated technology platform for adaptive clinical trials

DUBLIN--(BUSINESS WIRE)--Oct. 1, 2018-- (NASDAQ: ICLR) a global provider of drug development services to the pharmaceutical, biotechnology and medical device industries, today announced the release of ADDPLAN® neo, providing an advanced validated integrated technology platform for design, simulation and analysis of adaptive clinical trials.

The new release combines ADDPLAN® BASE, ADDPLAN® MC (for Multiple Comparison Designs) and ADDPLAN® DF (for dose ranging and dose finding trials using MCP-Mod methodology) modules under one umbrella, increasing simulation speed for each application and allowing computation of multiple projects on one, integrated robust framework. The software has been rewritten using C programming language to ensure efficient usage of computing resources and fast simulation results.

Following feedback from customers, ICON enhanced the algorithms’ stability and speed and added new features such as the ability to incorporate custom R code in the ADDPLAN® neo Dose Finding module.

Additional ADDPLAN® neo features include:

• Every-Phase Capabilities – Strengthen and advance study design, simulation and analysis for every phase of drug development, including Adaptive MCP-Mod, critical for dose-finding designs.
• Improved User Experience – A fully validated, graphical user interface (GUI) software, ADDPLAN® neo features a quick access to adaptive approaches across all phases of drug development.

Andrew Garrett, EVP Scientific Operations said “With the recent FDA announcement of its Complex Innovative Designs Pilot Meeting Program, targeted at innovative trial designs to inform regulatory decision making, the door is very much open for adaptive and other types of innovative design. ADDPLAN® neo provides an integrated and increasingly flexible solution that truly supports this innovation agenda by providing a validated tool that helps convert theory to practice.”

About ICON plc
ICON plc is a global provider of outsourced drug development and commercialisation solutions and services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specializes 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 93 locations in 37 countries and has approximately 13,675 employees.

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

ICON/ICLR-G

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181001005399/en/

Source: ICON

ICON Media Contact
Lucinda Sandon-Allum
Weber Shandwick
+44 (0)20 7067 0548
lsandon-allum@webershandwick.com