Guest Column | July 30, 2025

CDISC's New 360i Helps Move Trial Design From Manual To Modern

By Julie Smiley, vice president, life sciences, and Charles Shadle, head of data science operations, CDISC

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As a clinical researcher, you know planning a study means juggling a dozen balls at once. You draft protocols, initiate clinical sites, build case report forms, nail down data sets, recruit patients, and make sure every detail lines up, typically across dozens of documents and numerous data sources. The process is slow and manual, consuming time and talent that could be spent on actual research. This is where CDISC 360 Implementation (360i) comes in, revolutionizing the way we run clinical trials.

Picture this: You are preparing for a phase two clinical trial for a new Alzheimer's disease drug. You need to track cognitive scores, behavior, lab values, and many other key endpoints. In the old world, each of those would mean more forms, more custom data sets, more manual copying and pasting, leading to exponentially more chances for mistakes. In the new 360i world, the clinical trial process shifts from manual to modern.

Digital protocols and biomedical concepts (BCs) are the foundational elements of 360i. A digital protocol is a living, machine-readable version of your study protocol. BCs are reusable building blocks or standardized, structured representations of clinical ideas and observations, and how they are represented in your data and analysis (systolic blood pressure, tumor size, and HbA1c, for example). Once the vision for 360i is realized, you will be able to select the endpoints (outcomes measured to assess the safety and efficacy of a treatment) for your study, and the system will pull together the correct BCs to map out your schedule of activities (SoA), which is a clear roadmap of what happens when and how often throughout the trial. This automation at the outset of a trial is just one of the capabilities 360i will offer to significantly reduce manual effort and streamline trial design.

Currently, study designers select the activities, determine timing and visit windows, and then BCs are mapped to each activity. While this process already helps promote alignment across the data lifecycle, we are still early in our journey. Our long-term vision is to fully automate this mapping, enabling real-time, metadata-driven design that connects protocol content directly to data collection, transformation, and analysis. We are actively laying the foundation to make this a reality.

360i introduces a more connected, consistent, and efficient future for clinical research. What once took months will be accomplished in days. CDISC's digital transformation is underway, and you have the opportunity to help shape the new paradigm.

How The ‘I’ In Innovation Benefits You

CDISC 360i transforms clinical development by digitizing protocols, aligning metadata across the data lifecycle, and enabling automation at scale. These innovations reduce inefficiencies, improve data quality, and accelerate time to insight — bringing life-saving therapies to patients sooner.

We know that clinical trial protocols are increasingly complex, with 76% requiring at least one substantial amendment (77% of which are deemed avoidable) costing up to $535k. With structured, reusable study definitions powered by the Unified Study Definitions Model (USDM) and BCs, organizations can reduce costly protocol amendments, streamline study startup, and improve cross-functional alignment. For example, study teams can design once and reuse protocol content downstream, enabling faster setup and fewer errors.

Also with 306i, automated generation of case report forms (CRFs), electronic and executable data transfer (eDT) specifications, and datasets that enable earlier insights will significantly reduce manual processes and ensure traceability. In one use case, up to 96% of study data tabulation model (SDTM) variables were auto-generated, resulting in a 5x productivity gain for programmers and biostatisticians.

In addition, real-time and embedded validation from study design through the analysis using the CDISC Open Rules allows issues to be identified early, before they reach regulatory submissions. This proactive conformance checking reduces the risk of queries and delays. Even clinical sites benefit from 360i's modular protocol design, which can be visualized and summarized to improve understanding, training, and execution.

By connecting protocol design, data collection, analysis, and submission in one cohesive framework, 360i delivers value across the ecosystem, from sponsors and CROs to regulators, sites, and ultimately, patients.

Help Shape The Future With 360i

Building on the CDISC 360 proof of concept launched several years ago, we have moved from theorizing to demonstrating 360i. CDISC is currently proving out 360i from protocol to submission-ready SDTM datasets using both Alzheimer's and breast cancer trials. However, transformation at this scale is only possible with the active engagement and support of the global research community.

Researchers, sponsors, regulators, and technology partners around the world are coming together to transform what is possible in clinical research for everyone. Many individuals are generously giving their time to 360i as volunteers, and organizations are providing in-kind dedicated resources and tools, as well as philanthropic and sponsorship support. Whether you are ready to collaborate, innovate, or sponsor, 360i offers several paths to make a difference.

Collaborate

Join CDISC pilots, roundtables, or contribute your expertise as a volunteer to help guide standards and tools that drive the future of clinical trials.

Innovate

Participate in the CDISC AI Innovation Challenge or engage with our Technology Vendor Roundtable to bring new ideas and technologies to life.

AI Innovation Challenge: The CDISC AI Innovation Challenge is a global call to vendors, researchers, and innovators to create AI/ML-driven solutions that advance the digitization and automation of clinical research using CDISC Standards.

Technology Vendor Roundtable: Collaborative forum for CDISC member innovators to engage on standards implementation, automation, and interoperability to ensure alignment while maintaining CDISC’s neutrality as a standards development organization.

Sponsor

Provide financial support to the technical infrastructure and resources needed to deliver industry-wide change,  and we will recognize you through our marketing and communication channels and ensure you are involved as a key contributor to the effort. Inquire Here (please select "CDISC Sponsorships" from the drop list on the form and include your interest in 360i Sponsorship in the message field).

By participating in these efforts, you will accelerate adoption of digital standards, foster cross-sector collaboration, and position your organization at the forefront of clinical research innovation.

Learn More About 360i

References:

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A version of this article was first published as a LinkedIn article. It is republished here with permission.

About The Authors:

Julie Smiley is the vice president, life sciences, at CDISC.







Charles Shadle is the head of data science operations at CDISC.