As a software vendor supporting Sponsors and Sites across the clinical research ecosystem, Florence builds workflows to enable compliant, remote-first trials. Every product decision we make is shaped by regulatory expectations. The current U.S. push for deregulation opens a critical conversation. But for those of us building the systems modern research relies on, deregulation shouldn’t mean weakening the foundation. It should be an opportunity to pursue harmonization, clarity, and alignment with global best practices. The goal isn’t just to shrink the rulebook, but to make it more usable.

The Patchwork of Guidance Slows Progress

Guidance documents are meant to clarify regulations, but in the clinical technology space, they’ve become a fragmented maze. Consider how many different guidance documents a single product might touch:

• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Q&A
• General Principles of Software Validation: Guidance for Industry and FDA Staff
• Use of Electronic Informed Consent in Clinical Investigations
• Part 11, Electronic Records; Electronic Signatures – Scope and Application
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• Use of Electronic Health Records Data in Clinical Investigations
• Electronic Source Data in Clinical Investigations

Each of these documents has value, but in isolation, they create unnecessary complexity and duplication. For clinical trial teams, this layered approach causes delays, inconsistent interpretation, and increases the risk of missing key expectations simply because there are so many separate documents to consult. Rather than enabling innovation, the current landscape often adds burden to those striving to run trials effectively and responsibly.

Contrast this with the European Medicines Agency’s Guideline on Computerised Systems and Electronic Data in Clinical Trials, which consolidates the topics from all of the above FDA guidances into a single, integrated framework. It’s easier to interpret, easier to apply, and better aligned with how technology actually functions in modern trials.

This kind of harmonization doesn’t weaken standards, it strengthens them. It allows global Sponsors, Sites, and Vendors to work from the same foundation, reducing compliance friction and increasing confidence across borders.

The U.S. now has a rare opportunity. If redirected, the deregulatory agenda could open the door to real progress: fewer duplicative documents, more coherent expectations, and better alignment with global standards like ICH E6(R3).

R3 introduced much needed consistency in data governance and technology enablement—themes already echoed in numerous FDA guidance documents. In many ways, R3 reflects where the FDA is headed. But here’s the challenge: R3 will ultimately become yet another guidance document layered on top of an already crowded field. And while its content is valuable, adding more guidance, without consolidation, only increases the regulatory noise.

Too many documents, even with the best of intentions, create the conditions for interpretation gaps, compliance inconsistencies, and operational delays. When multiple sources say similar—but not identical—things, trial teams are left guessing. Deregulation should aim to integrate new frameworks like R3 into a streamlined, cohesive structure, one that reflects modern expectations without multiplying complexity.

If innovation and compliance are to move in step, harmonization isn’t optional, it’s essential.

We’re not asking for a lighter touch, we’re asking for a clearer path. It should be about building a regulatory environment that supports innovation, protects participants, and adapts to how modern trials are conducted.

Let’s take this moment to rethink how regulation works. Let’s consolidate where we can, clarify where we must, and build a regulatory framework that enables the very innovation it’s meant to oversee.