Quality Initiatives

Westat is committed to providing quality contract research organization services to support our clients’ projects in accordance with the following:

  • Food and Drug Administration (FDA) and other applicable regulations,
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines,
  • Client requirements,
  • Westat policies, and
  • Standard operating procedures (SOPs).

To emphasize our commitment to quality, Westat has implemented the following:

Quality Board

The Quality Board consists of senior managers from Westat’s research areas. The board provides advice, oversight, and management-level support to the Quality Assurance (QA) Unit.

Quality Assurance Unit

The QA Unit promotes quality, education, and training through collaboration with project teams conducting client-based work.

The QA Unit consists of the Document Control and Auditing groups. These groups work together to verify and measure compliance with SOPs, Federal and other regulations, and business and best practices.

Document Control Group

The Document Control Group develops, maintains, and updates more than 80 SOPs with input from senior managers in various work areas. These areas include data management, regulatory affairs, data analysis, and site monitoring. This process ensures compliance with regulations and client requirements by developing a consistent standard of high-quality work.

The Document Control Group also provides training on and manages compliance with SOPs. This is accomplished with the support of a learning management system (LMS).

Auditing Group

The Auditing Group performs up to 40 internal audits yearly. The auditors confirm project compliance with applicable requirements and regulations by performing internal project audits. These audits verify that project activities and documentation comply with SOPs. This task ensures that business practices complement requirements, regulations, policies, and procedures.