ICON Launches FIRECREST Safety Letters and Site Question Management Supporting Regulatory Compliance and Increasing Site Supp...
February 08 2021 - 4:30AM
Business Wire
New solutions enable enhanced delivery,
tracking and management of drug safety reporting and medical
questions from sites
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 two new
digital solutions supporting clinical research sites and sponsors.
The FIRECREST suite of digital clinical solutions are now
integrated with the ICON Safety Reporting solution to enable
electronic acknowledgement of safety letters by principal
investigators, with full compliance tracking and dashboard
reporting. The FIRECREST Site Question Management solution
automates, accelerates and tracks medical questions from the site
for quicker resolution.
The pharmaceutical regulatory landscape is continually evolving,
making safety reporting increasingly complex. FIRECREST Safety
Letters is supporting sites to manage safety letters and increasing
transparency for sponsors. It enables faster sponsor reconciliation
of safety letters, both on-site and remotely, that are stored and
accessible in one location with single sign-on. The solution also
features compound level management, reducing duplication and
empowering the principal investigators, or assigned user, to
acknowledge safety letter receipt ensuring pharmacovigilance
regulatory compliance.
FIRECREST Site Question Management provides medical query
routing according to region and role, facilitating faster responses
to medical focused questions and providing governance of the
process. A record of the interactions and metadata are held
centrally in the site portal for oversight purposes and an
exportable excel document can be filed in the eTMF.
“The COVID-19 pandemic has highlighted the value of remote
clinical management including the use of digital tools. We are
delighted to announce the availability of two new FIRECREST
solutions that are increasing speed of process and regulatory
compliance.” commented Alison Liddy, Senior VP Site & Patient
Solutions at ICON plc. “FIRECREST Safety Letters and Site Question
Management are part of a range of digital solutions from ICON
focused on automation to help improve the efficiency of site
activities.
FIRECREST digital solutions drive measureable efficiency and
quality in clinical trials and are deployed by 18 of the top 20
pharma with 540,000 users across 233 different indications.
About ICON plc
ICON plc is a global provider of outsourced drug and device
development and commercialisation services to 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
employed approximately 15,250 employees in 94 locations in 40
countries as at September 30, 2020.
Further information is available at
www.iconplc.com/firecrest
ICON/ICLR-G
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version on businesswire.com: https://www.businesswire.com/news/home/20210208005046/en/
ICON Media Contact: Gareth Arnold Weber Shandwick Telephone:
(+44) 07944 688281 LDNWSWICONClinical@corp.ipgnetwork.com
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