Redefining CRA Workflows Through Intelligent Automation

In a recent video interview with Applied Clinical Trials, Michelle Longmire, MD, co-founder and CEO of Medable, discussed the role of agentic artificial intelligence (AI) in clinical trials. She highlighted that 45% of clinical development time is wasted due to delays and siloed data. Agentic AI aims to reduce this by leveraging technology in areas previously untouched, freeing up human resources for strategic work. The human-in-the-loop concept ensures that AI supports, rather than replaces, human decision-making. Integration of AI across legacy systems is facilitated by model context protocols, reducing manual effort. Automation handles routine tasks, while critical decisions remain human-controlled. No-code platforms for AI tools require clear job descriptions and validation similar to human training.

ACT: Tools like CRA-focused agents are beginning to automate monitoring tasks and communication. What tasks do you think are best suited for automation, and where should human involvement remain central?

Longmire: The idea of human in the loop versus autonomy of the agents is really important, and it really comes down to the work at hand. When I'm a CRA, I am looking across over 13 systems. Sometimes I'm just emailing a site to say, ‘Hey, can you provide me this one missing data piece?’ or ‘This site is enrolling faster. Let's kick off more drug supply now.’ Those are things like that might be fully automated because we have high fidelity data, we rigorously deploy frameworks that ensure the agentic data is highly accurate and some of those tasks are just not actually the final decision to be made, but are rote, routine, and tedious. Now, when you think about things like, ‘Hey, we're seeing serious adverse events in these sites, or in this particular site, or in this patient.’ Now, you don't want agentic AI to be running autonomously against that problem, so that's a great example of where you want human in the loop. The goal is really to shift the human focus from tedious and tactical to strategic. When you look at the current clinical development work, over 90% of the human effort is in the zone of tedious and tactical. That's against our current survey of the jobs to be done, and the CRA is a great example of that. It's really about leveraging autonomy where it's appropriate, rote tasks, the tedious and tactical work, and then ensuring you have human in the loop very significantly, and validating those human decisions, providing them with more optionality, elevating human decision making with the strategic decisions that need to be made.