Quality is the cornerstone of ICON’s success. We’ve worked hard to establish a reputation for quality and have been recognised as one of the world’s leading Contract Research Organisations through a number of high profile industry awards.
ICON has an excellent track record of successful audits from regulatory bodies and clients. Since 2008 we have been subjected to >1,500 audits by our sponsors, >80 audits by regulatory bodies, >90 ISO audits and over 9,000 internal audits.
The quality of our work is vital to our mission of bringing better medications to patients around the world. We are committed to maintaining, supporting, checking and improving our quality systems to exceed the quality standards demanded by our clients, patients and regulatory authorities.
ICON’s Quality Management System (QMS) comprises our mechanisms for ensuring that all our services are performed to the highest ethical standards, conform to all relevant regulatory requirements and satisfies contractual obligations. The QMS is based on continual improvement, with ongoing measurement of process performance to determine the effectiveness of the QMS. The sequence and interaction of each process is defined, including the methods for control and the metrics for measuring overall effectiveness. It is proactive, data driven and capable of detecting signals and trends, profiling and addressing risks to keep projects Inspection ready at all times.
ICON's comprehensive quality system is constructed from the following key elements:
The key elements are further defined in the graphic below:
The state of the QMS is reviewed regularly to ensure that it is current and functioning effectively. Through audits & data analytics, we detect signal and proactively address risks to make better business decisions. Utilizing effective training and good documentation practices, ICON demonstrates regulatory compliance and consistency in our pursuit of being a trusted partner.
ICON has a comprehensive library of global Standard Operating Procedures (SOPs) which:
All ICON's activities are conducted in compliance with these global procedures and, when necessary, office specific or region specific procedures may be prepared. In addition, we have the flexibility to operate with our client's SOPs when requested.
SOPs are reviewed regularly for continuing suitability and are updated as required. All our SOPs are available for viewing in any of our offices.
In addition to providing in-house Quality Assurance auditing for clinical trials, the Quality Assurance department provides stand-alone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GVP (Pharmacovigilance), GMP and GLP regulations.
ICON has the resources to meet all your auditing requirements for both Medical Device and Drug including Preclinical/Phase I, and Phase II - III clinical trials and post-marketing activities. With QA personnel located across Europe and the US, Asia-Pacific, Latin America and Japan, the ICON QA team is flexible enough to provide an individual and personalised service for locally managed projects.