By Laetitia Soudanas, Senior Director of Clinical Solutions at Biorce

Through its RTCT initiative, the FDA is moving toward real-time clinical trials, reviewing safety signals, endpoints, and operational data while studies are still running.

That shift has direct implications for the operational layer supporting a trial. Visibility, traceability, and responsiveness are no longer internal benchmarks. They are what real-time oversight requires.

[H2] Where interoperability gaps show up

Real-time oversight starts with data that actually moves, across sites, sponsors, CROs, and technology platforms. In other words, without people manually bridging gaps at every step. Yet interoperability in clinical trials remains the exception rather than the rule, and its fragmentation tends to surface:

• Protocol updates queued for weeks while teams manually push changes across systems

• Safety signals delayed because relevant data lives across platforms that don't communicate

• Site readiness stalled by disconnected contracts, documents, and workflows

These delays have long been treated as operational realities. Increasingly, they point to something more structural: an infrastructure problem.