Austin, TX, 30 October 2025 – A newly published study in Alzheimer’s & Dementia demonstrates the critical role of data standards in advancing Alzheimer’s disease and related dementias (ADRD) research. The study compared alignment between the Alzheimer’s Disease Research Centers (ADRC) Uniform Data Set (UDS), HL7® Fast Healthcare Interoperability Resources (FHIR), and Clinical Data Interchange Standards Consortium (CDISC) standards.
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Austin, TX, 27 October 2025 – The Danish Medicines Agency (DKMA) previously announced that, effective 1 September 2025, data submitted for the assessment of marketing authorization applications and variations must be provided in CDISC format. This includes applications containing bioequivalence data, which will need to follow CDISC Standards.
The requirement applies to:
Austin, TX, 16 October 2025 — The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce their collaboration with Verisian, a London-based software company specializing in traceability and AI solutions for clinical trial analysis, validation, submission, and review.
An initial project to perform a gap analysis to assess the feasibility of using the CDISC Study Data Tabulation Model (SDTM) for representing 43 Self-Management Item Sets (SMIS) identified by the Japanese Collaborative Committee for Clinical Informatization in Diabetes Mellitus (CCCIDM)1 was completed with findings reported2.
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.
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.