By Clinical Research News Staff 

December 9, 2025 | The FDA’s decades-old regulation 21 CFR Part 11—which establishes criteria for electronic records and signatures to be considered trustworthy and equivalent to paper records—is in dire need of an update. Doug Bain, founder and consulting partner of ClinFlo, has his own proposal on reformations to streamline clinical trials and improve experiences for patients, sites, and sponsors, which he discusses extensively in this month’s episode of the Scope of Things. 

Bain explains that 21 CFR Part 11 was created in the early days of the internet and therefore no longer aligns with today’s digital research ecosystem. Current regulations often slow trials down, introduce inefficiencies, and create burdens for users, particularly sites and patients.  

A central element of Bain’s blueprint is the creation of a Trusted Third Party (TTP) to oversee shared clinical trial technology infrastructure. Currently, sponsors license and own technologies involved in clinical trials using an electronic data capture platform, leading to a “certain levels of inefficiency”, such as not being able to move forward with training, no single sign-on, and more. A TTP could allow different stakeholders to sign up and access the platform beyond just a single study or a single sponsor, as well as manage and validate the security to ensure it always works. 

Another reform Bain discusses is retiring the long-used term “source data” in favor of “authoritative data.” He argues that the insistence on all electronic trial data be checked with the original record—usually some kind of handwritten record—is counterproductive because it is outdated and less accurate than modern electronic systems, which implement edit checks, protocols, and validated standards. He states that the electronic systems are more reliable than “whatever was scribbled out in a post-note.”  

Bain believes his ideas align with the FDA’s broader modernization agenda. He emphasizes that he is not advocating for the dismantling of the regulatory framework. Rather, he is urging updating interpretations and expectations to reflect technological advances.  

To hear Bain speak more about hypertrials and the next steps of the FDA’s experimentation phase and to learn about the latest news on a novel women’s health and menopause initiative, a regenerative therapy for spinal cord injury, and more, listen to the latest episode of the Scope of Things.