Quality


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 >1,700 audits by our sponsors, >110 inspections by regulatory bodies, >95 ISO audits and over 11,000 internal audits.

  • 1,700+ sponsor audits
  • 110+ regulatory inspections
  • 95+ ISO audits
  • 11,000+ 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.

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 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:

  • Process
  • Compliance
  • Quality Assurance
  • Risk
  • Analytics & Reporting

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.

Standard Operating Procedures

ICON has a comprehensive library of global Standard Operating Procedures (SOPs) which:

  • Ensure that 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 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.

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