A statistical analysis plan template is a standardized, regulatory-aligned framework that details the specific methods for analyzing clinical trial data. It serves as a comprehensive blueprint for the analysis, ensuring all procedures are prospectively defined, objective, and reproducible. This technical…
A clinical study report (CSR) template serves as the standardized framework for authoring the comprehensive account of a clinical trial for regulatory authorities. This structured blueprint, designed in accordance with guidelines like ICH E3, ensures that all critical information is…
The volume of documentation generated during a clinical trial is substantial, and its organization is a critical operational and regulatory requirement. The DIA Trial Master File (TMF) Reference Model provides a standardized framework for this purpose. The model is not…
A regulatory document management system (RDMS) is a specialized platform designed for authoring, managing, reviewing, approving, and archiving the extensive documentation required for clinical trials and regulatory submissions. Unlike a general-purpose digital filing system, it functions as a controlled environment…