Clinical Readiness Study (vs. Clinical Trial)

A "clinical readiness study" is different from a full clinical trial. It's the work done *before* a trial to make sure the trial can actually happen. This includes: - Patient screening: Identifying which patients meet the criteria for the trial - Outcome measures: Deciding exactly which tests and assessments will be used to measure whether a drug is working - Standardization: Making sure all the measurements are reliable and consistent across different sites - Regulatory groundwork: Preparing the documentation the FDA will need to review - Site selection: Identifying which hospitals can run the trial Why it matters: Clinical trials are expensive and take years. Before you spend millions on a trial, you need to be absolutely sure the infrastructure is ready. A "clinical readiness study" is the final prep phase — like rehearsing a play before opening night.