CDISC 360i is transforming clinical research by digitalizing study design through analysis making metadata interoperable across the entire study lifecycle.

With connected standards and end-to-end automation, 360i eliminates manual tasks, enables AI, ensures traceability and consistency, and empowers the industry to deliver results faster, with better quality, and at a lower cost accelerating the delivery of new therapies to patients.

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360i Progress Report: 2025 Achievements

Design, Build, Run: The Teams Bringing 360i To Life

In 2025, together with our global community, we launched and advanced the 360i vision through the tactical work of the 360i Operational Team, the “Art of the Possible” prototype, an AI Innovation Challenge, and our Technology Vendor Roundtable.

The 360i Initiative officially launched in March 2025 and quickly gained momentum. The 360i Team fostered extensive industry collaboration, bringing together ver 80 individuals across several project teams (Design, Build, and Run, along with an Operational Steering Committee, Reviewers, and Parallel groups to work on key outcomes including CDISC open rules, biomedical concepts, and analysis concepts).

The 360i Team set out to transform the clinical research process into a dynamic, non-linear model - one where steps and phases can run in parallel rather than in sequence, and data flows seamlessly from one stage to the next. Along the way, we gathered valuable lessons. Where did we make progress? What insights did we gain? And, how far have we come?

Team	Achievements	Lesson Learned
Design	Developed several detailed user stories spanning from study design through study amendment - an important step toward aligning roles across our industry. This exercise confirmed that standardizing and linking biomedical concepts is highly effective, and it provided clear evidence of how these connections enable downstream use cases.	Linking concepts works but concept grouping are needed for usability Tools and standards must come together and robust tools needed to prove semantic layer Identified missing metadata to complete the end to end linking of information
Build	Successfully used biomedical concepts linked to USDM to generate dataset specializations as well as generation of define.xml and shell data sets.	Automation more complicated based on existing process flow Missing operational metadata is required to close the gaps and drive the automation
Run	Demonstrated ability to process data from a wide range of sources and automate generation of SDTM data and terminology mapping as well as expanding use of AI and ML to help support development.	Limited raw source data to test all scenarios Again, various gaps in missing operational metadata required to robustly drive the automation

The 360i Team produced a series of video demonstrations of key 360i deliverables showing this really works! This included the generation of a Digital Protocol with USDM, creation of CRFs and aCRFs, automating creation of the define.xml, , SDTM Dataset Generation, and Dataset Standards Conformance - accessible via a Google Colab notebook. These demos exemplify progress toward a flexible, non-linear clinical research lifecycle.

A Connected Future: The Art of the Possible

At the US Interchange in October 2025, we shared our vision for seamlessly integrating CDISC Standards into platforms to pave the way for true automation. With support from PwC, CDISC developed a “clickable prototype,” a wireframe for a potential software tool to help visualize the future of end-to-end standards.

To illustrate this concept, we used an Oncology Study as an example, connecting the prototype to the CDISC Library with standardized, digitized assets from the Breast Cancer Therapeutic Area User Guide (TAUG). We demonstrated how users can start their study by easily selecting endpoints, quickly moving on to configure study details. Biomedical concepts link directly to the Schedule of Activities, making it easy to edit, add, or import information from other studies. Next, users move on to configure analyses, preview outputs, review datasets, and even interact with a traceability map. Throughout the process, AI works behind the scenes to verify choices in real time, ensuring accuracy while keeping the “human in the loop.”

The prototype illustrates what becomes possible with just a few clicks when CDISC Standards are implemented as linked metadata, harnessing automation, and increasing efficiency. By delivering a visual representation of what is achievable, we delivered a touchstone for a fully connected future.

Catalyst For Automation: AI Innovation Challenge

The 2025 CDISC AI Innovation Challenge, a global contest launched in June 2025, directly supported the 360i initiative by serving as a catalyst for its vision of an automated, modern clinical research lifecycle. Accelerating the digitization and automation of clinical research using AI, Machine Learning, and CDISC Standards, the Challenge focused on three targeted AI/ML use cases to advance the digitization and automation of clinical research using CDISC standards.

Use Case #1
Protocol Library: Participants created a USDM-centric repository by extracting legacy protocol content using AI/ML, with thirteen submissions making it the most popular challenge.

Use Case #2
BC Acceleration: This challenge showcased AI/ML-driven approaches to accelerate the development and curation of Biomedical Concepts, receiving five strong submissions.

Use Case #3
Automated Traceability: Participants demonstrated semantic traceability from statistical analyses back to source data using CDISC standards, resulting in four compelling submissions for this complex use case.

The response to the 2025 CDISC AI Innovation Challenge underscored growing momentum and creativity surrounding the use of AI and ML in clinical research. Participants from across the globe demonstrated technical excellence, forward thinking, and a shared commitment to advancing standards-driven innovation for the benefit of the entire research ecosystem.

A Seat at the Table: Technology Vendors On 360i

This collaborative initiative brings together leading technology vendors from the CDISC member community to accelerate the development and adoption of CDISC Standards, advancing the 360i vision for a connected and modern clinical research lifecycle. By fostering innovation and interoperability, the initiative ensures that CDISC standards remain practical, scalable, and aligned with emerging digital workflows.

Throughout 2025, the roundtable convened multiple times virtually and in person at the US Interchange in Nashville, creating a forum for dialogue, problem-solving, and strategic alignment.

These sessions play a pivotal role in shaping the future of clinical trials by enabling vendors and developers to build tools that integrate seamlessly with CDISC’s structured metadata and digital protocol models. The outcome is a stronger ecosystem of solutions designed to support automation, improve data quality, and reduce inefficiencies across the research continuum.

To join the member roundtable, please complete this form.