Pharmacovigilance

Seamless and transparent pharmacovigilance solutions

Thorough collection and assessment of product safety information is essential to the success of clinical research studies and to maintain post-marketing product licenses. Our team of over 1200+ global Pharmacovigilance staff members bring together all safety services into a seamless and transparent delivery solution, with easy to review outputs, a strong focus on continuous quality improvement, and operational efficiency.

• Safety Reporting Solution
• Affiliate Level Solution
• Low-cost high-quality case processing model
• Assigned functional lead for clear communication routes and accountability
• Robust regulatory intelligence for over 90 countries
• Global reach and 24/7 coverage for Clinical Trials, Post-Marketing and Medical Device submissions
• Over 99% compliance with regulatory reporting timelines

Support in a changing regulatory environment

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.

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

We offer a range of safety resourcing models to our clients that can be developed into a customised solution to meet your study requirements:

• Unit based model
• Full-time equivalent (FTE) based model
• Embedded SolutionsTM staffing model
• Workforce transfer – transfer safety staff to ICON

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

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.

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.