The Protocol is a weekly review of regulatory change, methodology, and AI/ML developments in clinical biometrics. It is written for biostatisticians, data managers, statistical programmers, QA leads, biometrics directors, biotech executives, and the vendors who serve them at sponsors and CROs.
Each issue surfaces what changed this week in the standards, guidance, and published methods that biometrics teams have to act on — not what made industry headlines. We name regulators, sponsors, trial IDs, and guidelines. We say when something is uncertain or contested.
New issues land each Monday. The full archive is available at /issues.