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Lindus recently submitted a public comment to the FDA on the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). We support the pilot and believe it can be designed to answer harder questions than the request for information currently sets up. 

At Lindus, we believe AI will empower our tech organization to build better products. LLMs are unlocking potential across product management, design, and engineering, in ways that would have seemed far-fetched even two years ago. But the way we work is changing fast, and we think it's worth sharing what that looks like in practice.

What James Lind would ask us on Clinical Trials Day is whether the systems we have built are worthy of the participants, sites, investigators, and teams who make clinical research possible.We do not think they are yet, but we know they can be.

"The data pipeline, from medical record retrieval to structured EDC output, has to be designed for regulatory scrutiny from the start. Retrofitting data quality into an operational model that wasn't built for it creates avoidable risk at exactly the wrong stage of a program."

Every cancer case in a large screening trial must be fully documented, with complete diagnostic, staging, treatment, and outcome data. Losing even a small number of cases to incomplete follow-up can undermine the statistical power the entire study was designed to achieve. The operational model has to be built around preventing that from the start.

"Clinical trials for diagnostics are increasingly time-consuming and expensive, given the large volumes of patients required. Identification and proper enrollment at accredited sites alongside novel methods of reaching patients remotely are promising developments for speeding and focusing efforts."

Last week, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics. It is a welcome step toward faster, more practical clinical development that puts patients first, especially those for whom a clinical trial is often their best hope.

JPM is a peculiar thing. Thirty-plus meetings crammed into hotel lobbies, rooftop bars, and the occasional 50th-floor conference room with actual views. The sun came out again this year - two years running now. That felt symbolic somehow. Here’s what I noticed:

Listen to episode 3 of our podcast "Off Protocol", where guest host Zara Liew sits down with Dr Michelle Griffin to discuss an area of women’s health that has long been overlooked: heavy menstrual bleeding.

Michael Young, Co-CEO of Lindus Health, outlines how digital tools are enabling faster insights, better patient experiences, and smarter outcomes from protocol design to patient follow-up.