Development of Statistical Analysis Plan
Based on the protocol and in close cooperation with your company and its needs, our senior biostatisticians will develop the statistical analysis plan (SAP) for your study. Our SAP will provide clear specifications 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 biostatisticians will provide your company with statistical analyses that closely follow the statistical analysis plan (SAP) developed for your clinical study, complete with thorough quality assurance, ensuring that deliverables will meet your own high standards and those of the regulator.
Our biostatisticians 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 biostatisticians can consult on the best approach to interim analyses for your project, providing sample size adjustments, if necessary.
TechnoSTAT has extensive experience in writing biostatistical reports for regulatory agencies. All our regulatory reports are produced in accordance with relevant guidelines and are GCP compliant.
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