Faro

About Faro

Faro provides an end-to-end AI-powered platform that transforms clinical trial design, review, and optimization. Faro’s flagship product, Faro Study Designer, enables sponsors to author protocols in a digitally native, USDM-aligned format, connecting biomedical concepts, controlled terminology, and operational insights into a unified data model. By automating design and analysis workflows, Faro helps sponsors reduce study complexity, improve quality, and accelerate startup timelines across the clinical development lifecycle. 

CDISC Membership: Staying Ahead of Change

Faro’s mission aligns directly with CDISC’s vision of achieving global data interoperability. We joined CDISC to actively contribute to the next generation of standards - particularly as initiatives like Biomedical Concepts and USDM redefine what a digital protocol should look like. Membership enables Faro to stay aligned with evolving models while influencing how standards adapt to new technologies  

CDISC Membership has allowed Faro to stay ahead of change by collaborating directly with standards’ developers, sponsors, and regulatory stakeholders. Through early access to draft models and terminology updates, Faro can ensure our AI agents and digital protocol models remain compliant and interoperable. This helps sponsors build once and reuse everywhere, driving efficiency and consistency across the protocol lifecycle. 

CDISC Membership underscores Faro’s commitment to advancing digital trial design through structured, interoperable and technology enabled solutions. Our investment ensures that every enhancement whether it’s in AI authoring, review insights, or transformation engines is grounded in globally recognized data models. This alignment helps ensure that Faro’s innovation contributes meaningfully to the industry’s shift toward machine-readable, interoperable data ecosystems. 

Faro Health also benefits from engaging in the CDISC Interchange, a global event that brings together the clinical data standards community, and the CDISC 360i initiative, which focuses on advancing automation and interoperability through standardized, metadata-driven models. These collaborations provide valuable insights that help Faro strengthen its approach to digital protocol design and data standardization across the clinical research ecosystem. 

Faro and CDISC: Meeting at the Crossroads of Innovation

CDISC Standards are the connective tissue of Faro’s platform. They ensure data integrity across every stage from design to analysis by providing structure, meaning, and traceability. As AI reshapes how we process and generate data, these standards are becoming even more critical: they define the context that allows AI models to learn correctly. In essence, “garbage in, garbage out” applies - the better our standards, the smarter our automation. 

Our teams rely on the CDISC Controlled Terminology, Biomedical Concept BCL, and USDM specifications as foundational inputs to Faro’s data model. These resources make it possible to automate mapping, generate machine-readable study definitions, and ensure semantic precision across all data layers. CDISC’s training workshops and community webinars have also been instrumental in helping our teams interpret evolving standards and anticipate how they’ll connect with regulatory frameworks like ICH M11. 

For the CDISC AI Innovation Challenge, we applied CDISC Standards, particularly the Unified Study Definition Model (USDM) and Biomedical Concepts to automate protocol interpretation and optimization. Standardizing study definitions improved efficiency by reducing manual review time, enhanced collaboration by allowing cross-functional teams to work from a shared digital protocol, and strengthened outcomes through more consistent and higher-quality study designs that can be rapidly translated into downstream systems. 

We communicate the value of CDISC Standards by showing how they enable consistency, automation, and interoperability across every part of the study lifecycle. Rather than viewing standards as a compliance requirement, we emphasize their role as the foundation for quality and innovation, ensuring data integrity, regulatory readiness, and efficiency. As digital protocol design and the evolution of large language models advance, we highlight how CDISC provides the structure needed to make this transformation interpretable, reusable, and scalable across teams and systems.