ICON Launches New Drug Safety Reporting Solution that Ensures Compliance through Automation

ICON Launches New Drug Safety Reporting Solution that Ensures Compliance through Automation

DUBLIN–(BUSINESS WIRE)–ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions
and services to the pharmaceutical, biotechnology and medical device
industries, today announced the release of a new drug safety reporting
solution based on an innovative cloud-based system, featuring automated
and configurable business rules. The solution ensures compliance in an
increasingly complex regulatory environment and enables the sponsor to
gain visibility into the safety profile of an investigational product
throughout its lifecycle.

Using regulatory intelligence from 80 countries, the system is
configured with date-stamped decision rules. This facilitates the
required safety information to be submitted and distributed
automatically to all relevant stakeholders including Investigator Sites,
Ethic Committees, Institutional Review Board and Competent Authorities
within due dates. Safety information is submitted in the mandated format
in each case and a fully auditable distribution trail is provided.
Overall, this leads to higher quality, increased speed and regulatory
compliance. In addition, compound level reporting removes duplication of
notifications to those sites participating in multiple studies
investigating the same compound, thereby reducing investigator burden.

The solution also features reporting functionality and a dashboard
showing both individual and aggregate submissions at a study and
portfolio level. This provides the sponsor with increased transparency
to monitor and manage drug safety.

“The regulatory landscape is continually evolving which makes drug
safety reporting increasingly complex,” commented Andy Garrett,
Executive VP Scientific Operations, “Combining our drug safety and
regulatory expertise with innovative automation elevates ICON’s safety
reporting by reducing the burden on investigator sites whilst showing
clear benefits in terms of regulatory compliance”.

The system used in delivering this enhanced service to sponsors is built
on the Pega 7 cloud platform, a market leader in AI and business process
management software. It can be deployed with any pharmacovigilance
safety database, including the option to use as a stand-alone solution,
avoiding additional sponsor technology expenditure.

ICON’s Automation Centre of Excellence is dedicated to streamlining
processes using Artificial Intelligence (AI) and Robotic Process
Automation (RPA) to maximise human capital to accelerate clinical trial

About ICON plc

ICON plc is a global provider of outsourced drug development and
commercialisation solutions and services to the 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 currently, operates from 93
locations in 37 countries and has approximately 13,680 employees.

Further information is available at www.iconplc.com


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 

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