This dual accreditation demonstrates Icon’s exceptional commitment to the highest global best-practice research standards and our ability to deliver a quality comprehensive cancer clinical trials program that meets industry-leading benchmark standards.
An Australian First – Icon Group achieves dual global quality certifications for research sites and workforce leadership
Icon Group (Icon) has become the first Australian organisation to be awarded the Global Quality Standard for Clinical Research Sites (GCSA), and silver level Workforce Process Quality Certification (WPQC) for our clinical trials program in Australia and New Zealand.
Excellence in research
These two certifications were awarded by the International Accrediting Organization for Clinical Research (IAOCR) following a comprehensive review and evidence-based assessment of Icon’s research site business operational processes (for GCSA) and workforce processes (for WPQC). The GCSA assessment team’s feedback highlighted Icon’s strong business partnership qualities and demonstrates genuine support for, and commitment to evaluation and improvement to our clinical trials program.
Throughout the process it was noted that Icon presents strong evidence of exceptional quality research practices and procedures, especially in the area of health and wellbeing, demonstrating how we are committed to raising standards for the industry, not just in Australia but internationally.
Icon Group Executive Manager for Research, Sophie Mepham said this recognition is a reflection of the entire research team.
“I’m extremely proud to be the first Australian clinical trials team to be awarded this internationally recognised clinical research site certification,” said Sophie.
“It’s a testament to Icon’s dedication to upholding patient safety and the delivery of a high quality comprehensive clinical trials program
“Research is part of Icon’s DNA; and our proven robust governance, processes and systems allow us to bring clinical trials to more places globally, while ensuring we maintain the highest standards of international quality across a broad geographical footprint.
“Thank you to the IAOCR team for their unwavering commitment to global research standards and to my research team for their hard work and dedication in achieving this international status.”
Comprehensive assessment
The GCSA certification journey involved a review and assessment of research business operational procedures and discussions with research staff to gain a full understanding of business practices that underpin the safe, effective delivery of clinical trials and the quality of both patient and sponsor/CRO journeys.
The WPQC further delved specifically into the quality of clinical research workforce processes and frameworks to ensure a high-performing, committed and competent team which is crucial for reducing risk and delivering high quality clinical research.
Chief Quality and Client Officer at IAOCR and GCSA, Sarah Everitt commended Icon’s extensive research capabilities.
Pictured: Some members of our research team.
“Icon achieved these certifications due to their impressive work and leadership,” said Sarah.
“The team was responsive, enthusiastic and there were clear roles and responsibilities within the organisation that made the certification process streamlined and efficient and made Icon a pleasure to assess.
“It was clear that the leadership team has invested a significant amount of time in developing a specific Icon Group identity and culture – this approach is paying dividends in the organisation.”
Icon’s research team look forward to implementing the recommendations from the audit and work towards gold accreditation across our Australia, New Zealand and Singapore clinical trials operations.
International standards
Independent global industry experts and opinion leaders supported the development of and ratified the comprehensive assessment frameworks used by IAOCR and GCSA. The GCSA Quality Standard for Clinical Research Sites was developed with the support of a Global Advisory board that included key stakeholders and leaders from across the industry including Pharma/Biotech, CROs, Government Bodies as well as Commercial and NHS Sites.
The GCSA Quality Standard reviews the following seven core business operational areas identified by Sponsors and CROs as being critical to the delivery of high-quality clinical trials: Governance; Site Business Strategy; Workforce Quality; Patient Engagement; Feasibility; Study Start-up & Initiation; and Study Management, Operations & Close Down. Complimenting the GCSA Certification, the WPQC provides a clear benchmark of the highest workforce process standards for both those working within the organization to pride themselves on, as well as for sponsor’s and CROs looking for a ‘trusted global clinical research partner’ with demonstrable evidence of quality workforce standards.
Whilst clinical research is a highly regulated industry, until now there have been no established standards by which sites can demonstrate that they are able to meet the expectations of sponsors, CROs and patients, and no way for sponsors or CROs to select clinical research sites based on clear quality standards which have been independently assessed at the organizational level. GCSA sets this much-needed industry standard for research sites to strive for and achieve; it allows sites to evidence and communicate their capabilities and differentiate in a crowded and increasingly competitive marketplace. Beyond the assessment and certification process, where required, GCSA will deliver individual, practical support on the areas for development to meet the standards and will work collaboratively with sites to achieve certification.
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