Share page on Facebook Share page on Twitter Share page on LinkedIn ICON is committed to exceeding the quality standards demanded by our clients, patients and regulatory authorities 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. 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. In the last five years: 2,650+ Sponsor audits 10,000 Internal audits 80+ Regulatory inspections 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. Quality Management System 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 are 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: Process Compliance Quality Assurance Risk Analytics & Reporting The key elements are further defined in the graphic below: Standard Operating Procedures ICON has a comprehensive library of global Standard Operating Procedures (SOPs) which: Ensure that all client requirements are met Enable employees to conform to and document all ICH GCP, and Regulatory requirements Ensure that all company activities are controlled and documented Provide guidance for staff development and training 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. Quality Assurance Services 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 Early Phase, 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. The following QA services are provided on a stand-alone or project-specific basis. Audits/ assessments cover: Phase I - IV GCP audits Medical Device audits Phase 1 Facilities Clinical Laboratories (GCP, GLP) Database and Statistical tables Computer validation Clinical Trial reports Technical and operational vendor/supplier audits, assessments and qualifications FDA/regulatory preparatory assessments Quality Systems (GCP, GLP) Safety Surveillance/Pharmacovigilance IN THIS SECTION Company history ICON in Asia Pacific ICON in Latin America Leadership Quality Environmental, Social & Governance ICON and You Connect with us Contact us Submit proposal request Update Email Preferences Global office locator ICON on social media Contact About ICON Results & Reports For Clients Therapeutics Services Insights Innovation Content Preferences Office locations ICON For Patients Volunteers Investigators Jobs & Careers Investors Suppliers News & Events Press Releases Mediakit Events Social Media Dashboard LinkedIn Twitter Facebook Youtube © 2021 ICON plc Disclaimer Privacy Site Cookies We use cookies on this website We use cookies to enhance your website experience. 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