Drug Trial Protocol Review overview

Reviews clinical trial protocol design and amendments -- evaluating primary and secondary endpoint definitions for statistical power, validating inclusion/exclusion criteria against target patient population feasibility, assessing randomization and blinding methodology, reviewing informed consent documents for regulatory completeness, verifying protocol alignment with ICH-GCP guidelines and IRB requirements, and analyzing site selection criteria against enrollment projections. Produces protocol review reports, feasibility assessments, and amendment impact analyses. Excludes patient enrollment execution.