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"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Last week, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics.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.

Every winter, millions reach for cold and flu products, yet few appreciate the clinical rigor behind those claims of “faster relief” or “reduced cough duration.” Running studies to substantiate these types of claims can be challenging.Unlike chronic or preventive conditions, cold and flu symptoms appear suddenly, usually resolve quickly and vary widely across individuals and seasons.

The digital transformation of the fertility space has brought us everything from period tracking apps to FDA-cleared digital contraceptives. Yet these tools are often grouped together under broad categories that obscure critical differences in their purpose and effectiveness.

Consumer health is a $6.3 trillion mainstream market with consumers prioritizing solutions that help them feel and look better and live longer. Yet in this crowded, fast-moving space, one principle stands above all others: trust is the foundation of strong consumer health brands.