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. Through this partnership, CDISC and Verisian have been working together to refactor the CDISC Open Rules Engine (CORE), an effort already underway to enhance performance, improve rule authoring flexibility, and accelerate the development of the CDISC Open Rules providing support for broader adoption of global clinical data standards.
CDISC’s Open Rules are a key component in ensuring that clinical trial data adheres to standardized formats, enabling consistency, quality, transparency, and traceability across studies. By partnering with Verisian, CDISC aims to accelerate the development of CORE making it more performant, flexible, and easier to use for developing, testing, and executing CDISC Open Rules for the global research community. This effort is already well underway and is expected to be completed in the near future. Importantly, this work has not impacted existing Open Rules or the ability of rule writers to continue authoring new rules during the modernization process.
“Working with Verisian allows us to combine the strength of CDISC’s established data standards with Verisian’s extensive experience with open-source solution development” said Chris Decker, CDISC President and CEO. “This effort will help sponsors, contract research organizations (CROs), solution providers, and regulatory authorities validate clinical trial data more efficiently, ultimately supporting faster delivery of safe and effective therapies to patients worldwide.”
Verisian’s platform enables sponsors and CROs to achieve faster, higher-quality programming and validation, shorten regulatory inquiry cycles through augmented submissions, and build the information infrastructure for clinical trial Agentic AI. By integrating these capabilities with CDISC’s Open Rules Engine, the collaboration seeks to enhance data integrity, accelerate review processes, and provide more powerful tools for study validation.
Tomás Sabat Stöfsel, and Henning Kuich, co-founders of Verisian, added, “We strongly believe in the mission of CORE and are excited to help accelerate its development. We share CDISC’s vision for CORE to enable faster, higher-quality delivery of therapies to patients, and we are proud to partner with CDISC in achieving this goal.”
This collaboration highlights CDISC’s commitment to neutrality, transparency, and advancing clinical research standards globally. By modernizing the CDISC Open Rules Engine, CDISC can accelerate the development of the CDISC Open Rules, enhancing data review, streamlining the clinical trial process, and providing researchers, regulators, and technology providers with improved capabilities and greater transparency in regulatory compliance. Through open, standards-based innovation, all industry partners benefit, supporting a more efficient and high-quality clinical research ecosystem.
CDISC continues to welcome volunteers to contribute to rule development. Those interested can join the CDISC Open Rules Accelerator Program; participation details and contribution guidelines are available on this link.
About CDISC
Clinical Data Interchange Standards Consortium (CDISC) creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the European Medicines Agency (EMA) and China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)3 global nonprofit charitable organization with thousands of partners, volunteers, and member organizations around the world.
About Verisian
Verisian provides software solutions that enable sponsors and CROs to achieve faster, higher-quality programming and validation, shorten regulatory inquiry cycles, and build the information infrastructure required for Agentic AI in clinical trials - ensuring transparency, trust, and confidence in every submission. It allows for studies to be completed faster, with fewer resources, at higher quality and lower cost. Verisian’s platform generates code traceability, connecting SAPs, specifications, data, code, results, and submission documentation, independent of standards, programming languages, or statistical computing environment. The resulting information infrastructure enables evidence-based agentic AI for clinical trials.
