What is the AI-Enhanced Protocol Analysis Tool?

The Protocol Analysis Tool is an AI-driven solution designed to enhance the quality and efficiency of clinical trials by automating key aspects of protocol evaluation and early risk detection.

The tool operates in three intelligent steps, where the output of each step serves as the input for the next. This streamlined automation reduces manual effort, improves risk management, enhances compliance, and ultimately supports patient safety and data integrity.


Step 1. Protocol Complexity Assessment

Goal: To minimize unnecessary complexity, ensure that the trial remains efficient, ethical, and focused on its primary objectives, and enable faster and more reliable results while maintaining participant safety and compliance

Input: Study protocol or protocol draft

Output: Overall complexity score​, individual parameter assessment & score​, conclusion and recommendations


Step 2. AI-Enhanced Identification of Critical to Quality (CtQ) Factors

Goal: To automate the identification of Critical to Quality (CtQ) factors such as Critical Processes and Data - crucial to the success of clinical trials

Input: Study protocol, company-specific Critical Processes and Data

Output: Study-specific Critical Processes and Data


Step 3. AI-Enhanced Risk Assessment Generation

Goal: To streamline the Risk Assessment process, enabling more efficient decision-making and ensuring compliance with Risk-Based Quality Management (RBQM) standards

Input: Study protocol

Output: Tailored risk assessment specific to the study, identified potential risks with guiding discussion questions and assigned risk categories


To learn how to access the Protocol Analysis Tool works and to explore each step in more detail, refer to the related articles.

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