ICON Launches New Drug Safety Reporting Solution that Ensures Compliance through Automation
05 Février 2019 - 9:00AM
Business Wire
Developed on platform deploying rule-based
automation for timely delivery of drug safety information
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 delivery.
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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190205005060/en/
ICON Media Contact:Lucinda Sandon-AllumWeber Shandwick+44 (0)20
7067 0548lsandon-allum@webershandwick.com
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