Left of the Board
Shaping the AI bets before anything gets built: strategy, governance, and adoption in clinical research.
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What real-time clinical trials actually demand
The FDA's Real-Time Clinical Trials pilot gets talked about as a regulatory shift. It's really an infrastructure one.
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All notes →Seven warning letters
A new study looked at every FDA warning letter issued from January 2022 through late September 2026, which comes to 3,011 letters, and found that only seven of them mention AI at all, and only one treated a company's use of AI as the violation itself. The authors are careful to…
Qualify the reviewer
One line out of the PDA/FDA Joint Regulatory Conference has stuck with me, which is an FDA speaker's caution against using AI for anything you aren't qualified to check yourself (it's summarized in PharmTech, from conference reporting). It sounds like common sense, and it is, but…
Counting agents
IQVIA's latest earnings call had a number that's going to get repeated a lot: 415 AI agents deployed, up from 192 in Q1. They also credited those agents with lifting win rates by two to three points. That's real traction, and it's tied to bookings, not just a demo count. But…