Life Science — Clinical Trial Regulatory Document Automation

Overview

The Clinical Trial Regulatory Document Automation DAG is designed to streamline the generation of essential regulatory documents, such as electronic Trial Master Files (eTMF) and electronic Common Technical Documents (eCTD), from clinical trial data. The primary purpose of this DAG is to enhance the efficiency and accuracy of document creation, ensuring compliance with regulatory requirements in the life sciences industry. The data sources include clinical trial datasets, regulatory guidelines,

The Clinical Trial Regulatory Document Automation DAG is designed to streamline the generation of essential regulatory documents, such as electronic Trial Master Files (eTMF) and electronic Common Technical Documents (eCTD), from clinical trial data. The primary purpose of this DAG is to enhance the efficiency and accuracy of document creation, ensuring compliance with regulatory requirements in the life sciences industry. The data sources include clinical trial datasets, regulatory guidelines, and predefined templates. The ingestion pipeline begins with the extraction of relevant data from clinical trial databases, followed by the application of transformation logic that integrates citations and references to ensure each document's traceability. Quality control measures are embedded within the processing steps to verify compliance with regulatory standards. The outputs of this DAG are stored in a document management system, enabling easy access and retrieval. Key performance indicators (KPIs) monitored include document generation time and adherence to regulatory requirements, providing insights into process efficiency and compliance status. The business value of this automation lies in reducing manual effort, minimizing errors, and accelerating the documentation process, ultimately leading to faster regulatory submissions and improved trial outcomes.

Part of the Fraud & Anomaly Analytics solution for the Life Science industry.

Use cases

• Reduces manual documentation effort and errors
• Accelerates regulatory submission timelines
• Enhances compliance with industry regulations
• Improves document quality and consistency
• Facilitates easier access to regulatory documents