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| Type | Public / Private |
| Headquarters | South County Business Park Leopardstown Dublin 18, Ireland |
| Key people | Mr. Ciaran Murray, Executive Chairman Dr. Steve Cutler, CEO |
ICON is a global provider of outsourced drug development services to biopharma, medical device, government, biosimilar and generic organisations.
We offer a full range of clinical, consulting and commercial services that range from trial design to full study execution, and from clinical to post-market commercialisation.
Our services are supported by in-depth therapeutic and regulatory expertise and market-leading technology and analytics. We are the only full service CRO that offers the knowledge, software and systems for adaptive trials.[1]
History
From a small team of 5 people in 1990, ICON now employs over 12,300 people across 87 locations in 38 countries. We have mainly grown organically, but have bolstered our growth through a number of strategic acquisitions which have broadened our service portfolio and have added scale to existing services.
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</ref>http://www.iconplc.com/news-events/news/icon-wins-best-contract-r/index.xml</ref>
2017 ICON acquires MAPI Group to become world’s 2nd largest provider of late phase services
2016 ICON acquires Clinical Research Management Inc. to extend presence in the government sponsored research market
ICON selected by Genomics England to support the world's largest genome sequencing project
ICON selected by ICHOM to develop world’s first global healthcare outcomes benchmarking programme
2015 ICON celebrates 25 years
ICON creates new global innovation hub in Ireland to advance clinical development
ICON acquires MediMedia Pharma Solutions to enhance market access and scientific communications capabilities
ICON acquires PMG Research Inc, an integrated network of clinical research sites in the US
ICON launches Medical Device and Diagnostics Research Group
2014 ICON acquires Aptiv Solutions, a market leader in adaptive trial design and execution
2013 ICON acquires staffing and FSP providers, ClinForce and Assent
ICON acquires Akos, an EU Provider of Pharmacovigilance and Drug Safety Services
2012 ICON acquires PriceSpective, a global value strategy consultancy
ICON acquires Chinese CRO, BeijingWits
2011 ICON acquires Oxford Outcomes, an international health outcomes consultancy
ICON acquires Firecrest Clinical, a technology provider specialising in site performance and study management
2010 ICON acquires Timaq Medical Imaging Inc.
2009 ICON acquires Veeda Laboratories, a UK Biomarker Lab
2008 ICON acquires US Phase I Provider Healthcare Discoveries
ICON acquires US Bioanalytical Lab, Prevalere Life Sciences
2007 ICON acquires European staffing group, DOCS International
2006 ICON acquires Outcomes Research and Health Economics specialist, Ovation Research Group
2005 ICON opens first Indian office in Chennai
2004 ICON acquires medical imaging specialist, Beacon Bioscience Inc.
2003 ICON acquires Medeval, a UK-based Phase I facility
ICON acquires US consulting firm, Globomax
Pharmacovigilance
Support from clinical trial stage to market monitoring
Thorough collection and assessment of product safety information is essential to the success of both clinical research studies and in maintaining post-marketing product licenses.
Our team of over 300 global Pharmacovigilance staff members will bring together all safety services into a seamless delivery solution that focuses on transparency, easy to review outputs, and with a strong focus on continuous quality improvement and operational efficiency.
- Low-cost high-quality case processing model
- Assigned functional lead for clear communication routes and accountability
- Robust regulatory intelligence for over 80 countries
- Centralised safety reporting
- Global reach and 24/7 coverage for Clinical Trials, Post-Marketing and Medical Device submissions
- Over 99% compliance with regulatory reporting timelines
Case Processing
A key factor in delivering successful projects is robust project documentation, managed by well trained project personnel. At ICON we maintain an extensive library of SOP and procedures governing our case handling and processing to ensure staff training and quality. In addition each client is assigned a functional lead who coordinates activities and ensures the quality of outputs that meet clients' defined Key Performance Indicators (KPIs).
Case processing capabilities include receipt, data entry, narrative writing, coding, quality control, medical review, query management, and safety submissions.
Over the last 3 years we’ve processed an average of over 30,000 reports/year.
ARGUS Safety Database
Using the Oracle ARGUS safety database, we configure a dedicated schema for each client. The system is FDA regulation 21 CFR Part 11 compliant and has the capacity for generation of all standard regulatory and periodic reports.
We can also support database migrations, having rescued ongoing studies from other CROs, as well as having transferred legacy database of over 5,000 cases.
Safety reporting intelligence
Keeping up to date with regulatory changes worldwide can be a challenge. Our dedicated team translates complex local and international legal regulatory requirements to a clear, compliant submission decision. We review legal documents from around the world, and are in direct daily contact with international regulatory bodies. The regulatory updates are maintained in an online system for real time access. This includes Competent Authority, Ethics Committee and Investigator safety set-up and expedited and periodic submission decisions for Clinical Trials, Post-Marketing, Medical Devices, In Vitro Diagnostics, along with scope for other areas. You can also avail of our Help Desk service for regulatory safety reporting queries.
EudraVigilance - for EEA coverage
If you are bringing your product into the EEA market, we can provide specialist technical expertise to advise you. Our trainers are trained directly with the EMA to cover EMA registrations, EudraVigilance submissions, and XEVMPD. Our experts participate in EMA organised training and development programs on a regular basis to ensure they are up to date with the latest regulatory conditions.
Specialist, expedited and periodic submission team – for end to end safety reporting
Our multilingual team of experts in Europe, Asia, Latin America and North America, have a proven track record of handling regulatory reporting. We have above industry standard retention rates, providing you with stable project teams and consistency in end to end safety reporting. Our dedicated IT team provides 24 hour support our software solutions enabling an around the clock service.
We can provide services to support Competent Authority, Ethics Committee, Investigator and Business Partner submissions Post-marketing and Medical Devices . We are experienced with various types of submissions, including country specific on-line portals. Our procedures ensure high quality and compliance in our reporting and a proven track record of submission to all countries. A dedicated Safety Reporting Quality Assurance team, will help you to maintain excellent inspection outcomes, with support from a stable Management team to provide oversight and governance.
Affiliate management from many to one
To significantly minimise the complications and cost of managing numerous affiliates around the globe, we offer smooth transition of affiliate PV processes to ICON which will allows you to deal with one vendor, receive one report, have one primary point of contact, wihich also limits the number of vendors to audit.
We have a proven record in delivering projects within the affiliate model across Asia, Pacific, Europe, North and South America, Middle East and Africa along with over 99% compliance in ICSRs submissions.
Global and local literature monitoring
ICON also has significant experience in literature search services, having performed this specialised service for the last 8 years using Pubmed and/or Embase.. We can provide both routine weekly monitoring and also for periodic report generation and signal management.
Our expert literature team performs local literature surveillance in accordance with local legislation and review search results from the Medical Literature Monitoring (MLM) performed by EMA.
Other Services
QPPV/LPPV/NRPP
Supporting you in a changing regulatory environment
In an ever changing environment you need to be well informed of how regulatory changes may impact your product strategy to assure compliance.
We have a cross-functional Regulatory Change Management team which drives readiness for:
- Amendments to Regulation (EC) No 726/2004
- Directive 2001/83/EC
- Commission Implementing Regulation (EU) No 520/2012
- Updated GVP Module VI, IX
- ISO ICH E2B(R3)
- ISO IDMP
- EU Clinical Trial Regulation No 536/2014 [2]
References
- ↑ https://www.iconplc.com/
- ↑ https://www.iconplc.com/services/clinical-research-services/Pharmacovigilance/
Verification history
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