Austin, TX, USA and Uppsala, Sweden – 22 January 2024 – A new collaboration between two leading organizations in global medical data has been announced to bring greater efficiency and certainty to regulatory bodies, industry, and the healthcare community, ultimately aiming to improve patient safety worldwide.
Historically, lack of interoperability has been a significant stumbling block to the effective sharing and use of medicinal product safety data. The strategic partnership announced today takes aim at the problem, combining the expertise of the Clinical Data Interchange Standards Consortium (CDISC) in clinical data standards with that of Uppsala Monitoring Centre (UMC) as the developer of WHODrug Global, the world's most widely used drug dictionary.
Together, CDISC and UMC will work to strengthen interoperability between CDISC standards and WHODrug Global for the benefit of users, regulatory bodies, and the broader healthcare community.
“CDISC is excited to expand our long collaboration with Uppsala Monitoring Centre to support the global community in connecting WHODrug Global with CDISC’s Study Data Tabulation Model,” said Chris Decker, President and CEO, CDISC.
“CDISC has been an important collaborator for many years. Formalizing our collaboration is a natural next step. We believe that it is critical that standard-developing organizations related to each other should unite and collaborate actively, and we are very happy to do this together with CDISC. True interoperability is paramount to empower global healthcare initiatives and ensure the seamless utilization of data among regulators and across the industry," said Peter Hjelmström, Director, Uppsala Monitoring Centre.
The collaboration will take the form of knowledge sharing, networking, and joint projects, and the partners will deliver training and presentations for their respective user groups, focusing on standards, best practice implementation, and interoperability. Furthermore, the two organizations will engage in continuous information sharing and will also oversee and review technical documentation related to CDISC standards and WHODrug Global, to ensure comprehensive understanding and alignment. CDISC and UMC will also promote and encourage participation in each other's user group events, conferences, and workshops.
CDISC is a global leader in clinical data standards for regulatory submissions, while UMC is recognized for its operational support to the WHO Programme for International Drug Monitoring and pharmacovigilance initiatives to advance the safety of medicines and vaccines globally.
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a robust framework for generating accessible clinical research data. Driven by the belief that the true measure of data is its impact, CDISC convenes a global community of research experts representing a range of experiences and backgrounds to harness the collective power to drive more meaningful clinical research.
About Uppsala Monitoring Centre
Uppsala Monitoring Centre (UMC) is a non-profit, self-funded foundation that works alongside the World Health Organization and other stakeholders to advance medicines safety. As a leader in the development of pharmacovigilance science and research methods, UMC explores the safety of medicines and vaccines and offers products and services used by health regulatory authorities and the pharmaceutical industry worldwide. For more than 45 years, UMC has provided scientific and operational support to the WHO Programme for International Drug Monitoring.
