In recent years, clinical research has become increasingly complex and expensive with longer drug development processes that result in the need for innovative solutions. To reduce the impact, regulatory authorities recommend organizations employ risk-based approaches focused on patient safety and clinical data integrity. The successful implementation of the principles of Quality by Design (QbD) in protocol development and risk-based monitoring demonstrably increase efficiency.
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The United States (US) 21st Century Cures Act of 2016 was developed to accelerate development of new therapeutics. The use of real-world data (RWD) in regulatory submissions for therapeutic development in the US is increasingly supported by US Food and Drug Administration (FDA) guidance. Registries are a recognized source of RWD for regulatory submissions to the FDA. Drug and Biologics submissions to the FDA must use the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) format.
Austin, TX – 17 February 2025 – CDISC is pleased to announce the appointment of Julie Smiley as Vice President of Data Science. With over 30 years of experience in life sciences and healthcare, Julie brings a wealth of expertise in data management, standards governance, metadata-driven automation, and digital transformation.
New York NY - 13 February 2025 – Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials, has announced their collaboration with the Clinical Data Interchange Standards Consortium (CDISC), to accelerate the generation of standardized concepts using AI. CDISC is an organization that develops data standards to streamline the collection, sharing, and analysis of clinical trial data on a global scale.
Austin, TX – 29 January 2025 – The Clinical Data Interchange Standards Consortium (CDISC) is proud to announce the appointment of Paul Fenton-Carter as Chair of the Trial Master File (TMF) Reference Model Steering Committee. Paul succeeds Karen Roy, who has served in this role for the past 11 years, making invaluable contributions to the advancement of clinical trial standards and processes.
Austin, TX – 16 January 2025 – The Clinical Data Interchange Standards Consortium (CDISC) is proud to announce its new Chair, Chair-Elect, and Board Members. These accomplished leaders bring diverse expertise and a shared commitment to advancing global data standards, furthering CDISC’s vision to amplify data’s impact to advance research and improve global health.
As we reflect on the past year, we are grateful for the incredible partnership with our CDISC community driving our mission to amplify data's impact. The passion and dedication of our volunteers, members, staff, regulators, and partners inspire us as we work together to shape the future of clinical research.
Austin, TX – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the return of Dr. Nicole Harmon, PhD, as its new Chief Operating Officer (COO). Dr. Harmon, a distinguished leader with over 20 years of experience across nonprofit, healthcare, research, and technology sectors, will oversee CDISC's operational strategies, furthering its mission to amplify data’s impact to advance research.
Austin, Texas, USA and Geneva, Switzerland - The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a clinical protocol template and technical specification to ensure clinical study protocols are prepared in a consistent manner and provided to users in a harmonised data exchange format acceptable to all regulatory authorities of the ICH regions. This protocol and electronic exchange format will facilitate the streamlining and exchange of protocol information and support future tool de
The purpose of this project was to understand the needs of Japanese researchers, to inform areas for new standards development to advance clinical research, and to expand collaboration between researchers in Japan and CDISC. This project was focused on reviewing the diabetes mellitus and associated chronic diseases Self-Management Item Sets (SMIS) identified by the Japanese Collaborative Committee for Clinical Informatization in Diabetes Mellitus (CCCIDM)1,2 and to assess how they map to existing CDISC standards.