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Presentient has received comments from FDA providing clarity on how sponsors can use BRAKES
The FDA comments clarify how the FDA anticipate BRAKES being deployed; sponsors seeking to use BRAKES in the context of a specific clinical trial are to engage with the FDA via individual IND submissions.
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Presentient Proposes Pilot in Response to FDAs AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program RFI
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Whitepaper: BRAKES helps trials stop years earlier
The BRAKES platform accelerates decision-making by months to years while eliminating operational bias.
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Stay blinded, decide sooner
Want to speed up your clinical trials with early decision making? Want to run 20+ automated interim analyses while eliminating operational bias?