We Need Regulatory Clarity—Not Complexity In Clinical Trial Technology

By Sara Saunders, Sr. Manager, Regulatory Affairs - Florence Healthcare

As the clinical research ecosystem embraces remote-first trials and digital innovation, regulatory clarity is more critical than ever. The current U.S. deregulatory momentum should not diminish compliance standards but instead serve as a call to streamline and modernize regulatory guidance. The current patchwork of overlapping FDA guidance covering electronic systems, signatures, consent, data use, and more creates confusion and operational inefficiencies. In contrast, the European Medicines Agency offers a more unified model with a single, comprehensive guideline that consolidates key regulatory themes. This approach strengthens regulatory expectations by aligning with real-world technological workflows and global standards. As the FDA implements ICH E6(R3), a forward-looking framework for data governance and technology enablement, the risk lies in further layering rather than integrating new guidance. Florence calls for harmonization across regulatory documents to eliminate redundancy, reduce interpretation gaps, and promote consistency in compliance. Software innovation in clinical trials depends not on less regulation, but on smarter, clearer regulation. The U.S. has a unique opportunity to reshape its regulatory landscape to better support innovation, protect participants, and accelerate responsible research progress.