Axtria has unveiled a groundbreaking artificial intelligence platform that promises to transform the creation of clinical study reports (CSRs), addressing one of the pharmaceutical industry's most time-consuming regulatory documentation challenges.
The new platform, Axtria Rapid CSR, leverages advanced generative AI technology to reduce CSR generation time by 30-50% for large-scale phase III clinical trials while maintaining over 90% accuracy in alignment with ICH-E3 guidelines.
Transforming Traditional CSR Development
Clinical study reports have historically required months of meticulous collaboration among multiple stakeholders to analyze and summarize complex trial data. The process involves crafting 16 distinct sections that detail study design, endpoints, methodologies, results, and conclusions across various data formats.
"We developed Axtria Rapid CSR to enhance efficiency in manual, error-prone tasks like interpreting clinical study data, deciphering complex tables and graphs, and analysing annotated case report forms to rapidly develop an initial, complete CSR," explains Luke Dunlap, Principal and Head of Clinical Solutions at Axtria.
Advanced AI Architecture and Capabilities
The platform employs a sophisticated multi-LLM approach that can process and interpret thousands of file formats, handling both structured and unstructured source documents. Its intelligent system can cross-reference multiple tables to create comprehensive summaries across different sections while maintaining regulatory compliance.
Particularly noteworthy is the platform's ability to draw critical inferences from multiple study data inputs, providing deeper context and relevance even for the most complex sections of a report. This capability has shown particular strength in generating accurate medical writing for safety and efficacy sections.
Impact on Drug Development Timeline
The acceleration of CSR generation has significant implications for the broader drug development process. By reducing the time required for regulatory documentation, pharmaceutical companies can potentially speed up their submission timelines while reducing costs.
"We have seen significant advances in our ability to generate accurate medical writing, particularly in the areas of safety and efficacy, where our solution draws critical inferences from multiple study data inputs, even for the most complex sections of a CSR," Dunlap notes.
Versatile Application Across Clinical Research
The platform demonstrates versatility across different types of clinical research, supporting studies ranging from early-phase trials to post-surveillance investigations. This flexibility makes it a valuable tool for pharmaceutical companies of varying sizes and research focuses.
Medical writers and clinical researchers benefit from the automation of repetitive tasks, allowing them to focus more on analytical and strategic aspects of their work. The high accuracy rate in data extraction and interpretation, combined with rapid section generation, supports more efficient regulatory submissions while maintaining quality standards.
