Development of Statistical Analysis Plan
Based on the protocol and in close cooperation with your company and its needs, our senior statisticians will develop the statistical analysis plan (SAP) for your study. Our SAP will provide clear specification and implement statistically appropriate methodologies. Where needed, we will work together with your company and the regulator to ensure that the clinical study report (CSR) will meet the agency’s requirements.
TechnoSTAT’s experienced statisticians will provide your company with statistical analyses that closely follow the statistical analysis plan (SAP) developed for your organization, complete with thorough quality assurance, ensuring that deliverables will meet your own high standards and those of the regulator.
Our statisticians and programmers hold advanced degrees and receive continual training in statistical methodology, programming and ICH requirements.
Depending on the design selected, TechnoSTAT can provide interim analyses for a variety of aims, including testing for superiority or futility, and/or for adjusting trial design via classical and Bayesian methods.
TechnoSTAT has extensive experience in writing statistical reports for regulatory agencies. All our regulatory reports are produced in accordance with relevant guidelines and are GCP compliant.