On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
BIMO
.
Show all posts
Showing posts with label
BIMO
.
Show all posts
Friday, April 25, 2025
Classifying Protocol Deviations - New FDA Guidance on Protocol Deviations
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In clinical trials, protocol deviations are generally unintentional departures from the IRB-approved protocol and are commonly not discovere...
Monday, October 21, 2024
FDA Office of Scientific Investigations (OSI) Requests for Bioresearch Monitoring (BIMO) Data for NDA/BLA Submission
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FDA has a Bioresearch Monitoring (BIMO) program and the BIMO program is managed by the Office of Scientific Investigations (OSI). BIMO pro...
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