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Development of an Automated Clinical Data Management and Analysis Platform for Streamlined Reporting and Regulatory Compliance








Development of an Automated Clinical Data Management and Analysis Platform for Streamlined Reporting and Regulatory Compliance


Anil Mogha


K3-Innovations, Inc






31 March 2025


Overview: The purpose of this project is to develop a software application that can help organizations better manage and analyze clinical trial data. Clinical trials produce large amounts of data that must be processed, analyzed, and reported accurately to ensure that new treatments are safe and effective. However, handling this data manually can be time-consuming and prone to errors.Background: Currently, many organizations face challenges in efficiently managing clinical trial data and generating the necessary reports for regulatory approval. These challenges are due to the complexity of clinical data and the need to follow strict regulatory standards. Our project aims to address this by creating an automated platform that can streamline data management, perform statistical analyses, and generate reports that meet regulatory standards. By automating these tasks, we hope to reduce the time and effort required, and minimize the risk of errors.Objectives: The main goal of this research is to develop a user-friendly software application that can automatically process clinical data, perform necessary statistical analyses, and generate standardized reports. This software will help researchers and organizations save time, improve accuracy, and comply with regulatory requirements. The project will focus on refining the software's capabilities and demonstrating its effectiveness using real clinical study data.



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Statistical Analysis Plan