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Why the FDA and Sponsors Support Research Sites Using AI
There’s a question a lot of research sites are quietly asking right now: what would a sponsor think if they found out we were using AI on their trial data at all?
Oliver Keh
podcast
Note to File: Oliver Keh
In this packed episode of Note to File, Oliver joins Brad Hightower and Denali Rose to talk about what’s on the mind of any site leader right now: How do sponsors actually feel about sites using AI, and what does the FDA have to say about it? Does eSource even need to exist? Why is data entry still such an unsolved problem in clinical research? What does the future of paper source look like? Oliver gets into Gleam's novel approach and how it's quietly revolutionizing the hands-on workflows and daily operations at sites, how the team infuses fun in a serious work tool, and more.
Brad Hightower
Denali Rose
product principles
Optimizing for Joy
I say this a lot when I’m building Gleam: I optimize for joy.
Michael Felix
Why We Start With Research Sites
A lot of clinical research software is selected by people who are not doing the day-to-day work at the site. They're not the ones handling queries, entering data, or trying to keep visits, documentation, and patient care moving at the same time.
Gleam team
Trust Is Built Field by Field
In clinical research, trust depends on being able to verify the work.
Good Clinical Research Software Should Fade Into the Background
Clinical research sites already have enough competing for attention: Source pages, CRFs, queries, patient visits, and study timelines all demand focus. Software should make that work easier, not add another layer to manage.
clinical trials
The Founder Initiative, Oliver Keh
How do startups find product-market fit? Oliver sits down with Adam O'Donnell to discuss Gleam's journey of self-discovery, forming authentic connections with the people whose challenges you've set out to solve, some wise words from Warren Buffett, and more.
Adam O'Donnell
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Move data from any source to any EDC, faster than ever. No complex installation. Zero integrations needed.