"Clinical research is a rapidly-growing, truly global industry with an estimated value of approximately A$92 billion according to Fortune Business Insights. However, with growth comes increased public awareness, increased possibilities and responsibilities, and increased risk. Unlike many other highly-regulated industries, there is no requirement for clinical research professionals or organisations to demonstrate appropriate competencies or to work to global quality standards. Industry leaders are left to decide whether process quality in terms of workforce and business operations quality are an organisational priority. It is therefore not surprising that according to the USA FDA a third of clinical trials fail. Competence and business quality standards are not compulsory. However, many organisational leaders are proactively and voluntarily seeking out best practice standards and reaping the multiple rewards that a “right first time” and “quality built in” ethos delivers. The International Accrediting Organisation for Clinical Research has been facilitating the development of industry best practice standards since 2011. Following five years’ research and development, GCSA – the global quality standard for clinical research sites was launched in 2023. Focused on true patient centricity and enabling synergistic working between sites and sponsors, the process encompasses assessment, process improvement, certification and marketing. In this session we will explain how global quality standards are developed. Delegates will also hear the story of Icon Group’s journey to achieving GCSA global clinical research site certification, and the learnings and results of GCSA Certification for a fast-growing community of sites around the world. During this session, conference participants will: • Gain an understanding of how global accreditation standards are developed • Receive an overview of global accreditation and certification processes • Hear about the Certification journey of Australia’s largest private cancer clinical trials site network • Learn about the results of competence verification at an individual and organisational level "