In this post our Founder and Chief Executive Jacqueline Johnson North shares how the GCSA Global Quality Standard was developed. Founded in 2011 IAOCR - International Accrediting Organization for Clinical Research is the world leader in #clinicalresearch #competence standards. Leveraging IAOCR's expertise in gap analysis, process improvement and quality and building on existing relationships with global industry leaders enables us to work across the industry - and across the world to help shape a better future for #patients.
Enabling clinical research sites, people and companies to build capacity, competence and efficiency. Best practice models built with the industry, for the industry - improving outcomes for patients. CEO & Co-Founder
#FAQ 1 of 12 : What makes this a global standard - how was it developed? CONTEXT OF THE GCSA QUALITY STANDARD : #Clinicalresearch is one of the world's few truly global industries. Sponsors often run #clinicaltrials in a number of countries simultaneously. Working with the industry, we developed a global standard that would benefit #patients, #sites, #workforce, #cros, and #sponsors - regardless of the type of site, type of trials, and regardless of location. IDENTIFYING BARRIERS - SPONSORS & SITES WORKING TOGETHER * Our 2017 Clinical Research Industry Leaders Think Tank highlighted key barriers to sponsors and sites working synergistical together. Fundamentally these issues impacted the patient experience as well as the site-sponsor relationship. * We formed a #GlobalAdvisoryBoard and worked with charities, global pharmaceutical companies and CROs, trade bodies, regulators, the #NHS, sites, and patient groups to understand key issues. * It became clear that global standards were needed to help support 7 key business process areas : #Governance #Workforce #CommercialStrategy #Feasibility #PatientEngagement #StudyStartUp & Initiation #StudyManagement Operations & Close Down * Drawing on #IAOCR's experience of building international standards, we developed assessment criteria and a methodology to help support sites on a seamless journey to embedding #worldclass business processes. * The assessment approach and criteria was ratified by the Global Advisory Board, tested in pioneer sites, updated and refined over a number of years before being officially launched in summer 2023. (SLIGHTLY OVER) ONE YEAR AFTER LAUNCH The vision shared by the Global Advisory Board is becoming a reality with site networks now certified across #Australia, #NewZealand, #USA, #Ecuador, and the #UK (both commercial and the #NHS) and many more being supported to achieve the standard. It's truly rewarding to hear the multiple success stories and benefits that all our #CertifiedSites are experiencing. Thanks to the many years of dedicated work with the Global Advisory Board, we're very proud to run a truly global standard - and to have #100% referenceable database of truly #happyclients. THANK YOUS #Thankyou to the original #pioneer sites that helped us to test and refine the standard Re:Cognition Health & London North West Healthcare NHS Trust - your passion for #bestpractice coupled with your belief and trust in us as we set out to create the standard was invaluable. Thank you also to our original GLOBAL ADVISORY BOARD for many years of support, insights and passion for improving research and patient experiences Parexel PPD Syneos Health The Association of the British Pharmaceutical Industry (ABPI) Allergan University of Oxford #NHS #HRA NIHR (National Institute for Health and Care Research) Novartis Re:Cognition Health IAVI Medicines for Malaria Venture The Research and Development Forum Dr Emer MacSweeney Victoria Toms (Nee Eyre) Christiana Dinah Sandra Johnson