Clinical trials have a connectivity crisis, not a technology crisis. Sponsors, sites, CROs, and regulators each hold data the others need, yet that data moves between them slowly, manually, and incompletely. A 2024 JAMA analysis found that trial data infrastructure has evolved very little over time, resulting in a fragmented system that limits the quality of evidence trials can generate. The operational cost is staggering: every week of preventable startup delay costs sponsors more than $390,000 in direct Phase III trial expenses, according to 2024 Tufts CSDD data.
But three standards are now mature enough to change the architecture. CDISC's Unified Study Definitions Model (USDM v4.0, released June 2025) lets systems read and configure trials from a single digital source. ICH M11, finalized in November 2025, creates the first internationally harmonized machine-readable protocol standard. And HL7 FHIR enables EHR data to flow directly into trial systems. Together, they offer a path from fragmented manual re-entry toward genuine interoperability. FDA is examining FHIR for regulatory submissions and finalized guidance on using EHR data for regulatory decisions in July 2024. Sites that understand these standards now will be better positioned as connected infrastructure replaces today's siloed workflows.