Clinical Data Interchange Standards Consortium Inc

What it reported doing in 2025

In 2024, cdisc introduced a strategic roadmap to expand and enable standards driven automation across the end-to-end study information lifecycle from study design through results. To realize this vision, cdisc is mobilizing its work around three key pillars: expand & connect, enable & automate, and engage & adopt. These three strategic pillars position cdisc and the industry for future innovation and transformation. With expand & connect, we aim to embrace and adopt digital study design, creating connected standards across the clinical research information lifecycle while defining a clear pipeline for integrating new data sources. Through enable & automate, we develop ready-to-use implementation standards that are enabled through technology, reduce variability and focused on interoperability and automation. Finally, engage & adopt establishes a continuous feedback loop across the cdisc community, prioritizing the needs of producers and consumers to lower the barrier to standards use, and increasing communication to better enable our stakeholders.this year, as we celebrated our 25th anniversary highlighting key partnerships, volunteers and impact. We initiated and advanced 360i, moving the industry toward a dynamic and standards-driven data flow with over 80+ contributors leading teams (design, build, and run), innovation challenges, and roundtables to shape the future of clinical research. The design team developed detailed user stories spanning from study design through study amendment and demonstrated the ability to leverage the digital protocol to automate downstream. A key achievement was embedding conformance considerations from the outset, using core and cdisc open rules to ensure standards conformance throughout the lifecycle. The build team successfully generated define.xml and shell datasets from the digital protocol identifying the metadata needed for automation. The run team demonstrated the ability to process data from a wide range of sources (e.g., crf, fhir rwd, dht) and leveraging open source tools to automate the generation of sdtm data sets from upstream digital study design information. Strategic collaborations strengthened this momentum, supporting modernization, expanding digital standards, and improving interoperability across study startup and data exchange. Our events and education offerings also saw strong engagement, building skills, expanding understanding, and fostering deeper alignment across the community.2025 technical milestones: -ai innovation challenge launched to galvanize global innovators to advance the digitization and automation of clinical research through ai, ml, and cdisc standards. With 22 submissions across three technically complex use cases, the challenge delivered practical, standards-driven solutions that strengthen interoperability, accelerate digital protocol development, and enable end-to-end traceability. -cdisc open source alliance (cosa) partnered across the global community met quarterly throughout the year to showcase their open-source solutions including hackathons and more than 15 open source solution demos and 8 oss additions to the repository. -technology vendor roundtable initiated to bring together cdisc members focusing on technology solutions in a collaborative environment to support cdisc's digital transformation. Participants discussed the future of clinical trial innovation by ensuring that cdisc standards are practical and implementable in modern digital workflows. It supports the broader 360i initiative by helping vendors and developers discuss tools that integrate seamlessly with cdisc's structured metadata and digital protocol models. -tmf marked a major milestone as it became the official cdisc tmf standard, transforming tmf rm v4 into version 1 of a unified, interoperable framework for clinical trial documentation. Additionally, the global tmf community advanced into the collaborative cdisc tmf community, embracing a data-driven, machine-readable future th

Financial Efficiency

• Mission deployment rate: 68.7%; rating input score 69
• Program expense ratio: 72%; rating input score 72
• Fundraising efficiency: $11.94 raised per $1 spent on fundraising; rating input score 42; 42nd percentile among comparable filings

Transparency & Controls

• Consistency checks: 100%; rating input score 100; 63rd percentile among comparable filings
• Pay-setting controls: 4 of 6 controls in place; rating input score 67
  • Compensation committee: Pass
  • Independent consultant: Missing
  • Other Form 990s reviewed: Missing
  • Written employment contract: Pass
  • Compensation survey or study: Pass
  • Board or committee approval: Pass
• Foreign activity oversight: Scored; rating input score 0
• Grant itemization coverage: Scored; rating input score 0
• Major donor itemization: Yes; rating input score 100
• Related-party transparency: Scored; rating input score 0

Accountability

• Independent voting board: 100%; rating input score 100; 63rd percentile among comparable filings
• Governance controls: 9 of 9 controls in place; rating input score 100
  • Conflict-of-interest policy: Pass
  • Whistleblower policy: Pass
  • Document-retention policy: Pass
  • CEO compensation review process: Pass
  • Other executive compensation review process: Pass
  • Form 990 shared with the board: Pass
  • Board meeting minutes documented: Pass
  • Audit committee oversight: Pass
  • Independent financial-statement audit: Pass

Sustainability

• Operating margin: 4.7%; rating input score 42; 42nd percentile among comparable filings
• Total-asset coverage ratio: 0.47; rating input score 15; 15th percentile among comparable filings
• Liabilities to assets ratio: 0.56; rating input score 14; 14th percentile among comparable filings
• Officer compensation ratio: 19.5%; rating input score 16; 16th percentile among comparable filings

Growth

• Program expense growth: 5.1% per year; rating input score 100; 36th percentile among comparable filings
• Revenue growth: 5.8% per year; rating input score 100; 43rd percentile among comparable filings
• Asset growth: 5.4% per year; rating input score 100; 35th percentile among comparable filings