Services
Statistical and regulatory support tailored to your project.
Semita provides the strategic regulatory foresight your project needs at every critical milestone of the development lifecycle.
Protocol and amendment review
Review of draft protocols and protocol amendments, with a focus on regulatory acceptability, study design, type I error control, estimands, and planned statistical analyses.
Regulatory interaction preparation
Support with preparing for EMA, MHRA, FDA, or other regulatory interactions, including review of draft briefing books and refinement of statistical and study design questions.
Regulator question anticipation
Help identifying the statistical and design questions regulators may raise, so teams can prepare clear, robust responses before meetings or submissions.
Meeting support
Attendance at regulatory meetings where needed, providing specialist statistical and regulatory input during discussions with authorities.
MAA evidence strategy
Strategic support for developing adequate evidence of efficacy for a Marketing Authorisation Application, including consideration of study design, analysis, and regulatory expectations.
CSR and submission review
Mock statistical assessment of clinical study reports and submission documents to identify potential regulatory issues before submission.
Authority question responses
Support with interpreting questions from regulatory authorities and developing clear, scientifically grounded responses.
Need support with a project?
Get in touch to discuss what you are working on and how Semita may be able to help.
Contact Semita