GenAI-powered solution delivers clinical study reports in minutes with 30%–50% faster turnarounds, 90% ICH-E3-aligned accuracy, and substantial cost savings.
Axtria Inc., a global cloud software and data analytics company for the life sciences industry, announces groundbreaking advancements in its Clinical Solutions practice with the launch of Axtria Rapid CSR, an innovative use of Generative AI for the processing and automation of clinical study report (CSR) development. Axtria Rapid CSR has been trained and tested to reduce the generation of these reports by 30%–50% for most large-scale phase III clinical trials.
“We developed Axtria Rapid CSR to enhance efficiency in manual, error-prone tasks like interpreting clinical study data, deciphering complex tables and graphs, and analyzing annotated case report forms to rapidly develop an initial, complete CSR,” said Luke Dunlap, Principal and Head of Clinical Solutions at Axtria. “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.”
Axtria Rapid CSR is capable of supporting studies of all sizes, from early-phase trials to post-surveillance.
- What this Does: Axtria Rapid CSR transforms clinical study reporting by streamlining the entire CSR authoring workflow, combining the power of artificial intelligence with human expertise to deliver superior results. This leverages multiple LLM approaches to consume data from thousands of file formats, summarizing both structured and unstructured source documents. Results adhere to ICH-E3 guidelines for formatting requirements and can cross-reference multiple tables to support a single summary across sections.
- Impact it Delivers: Axtria Rapid CSR delivers data extraction and interpretation with over 90% accuracy in completed experiments and generates report sections in minutes, enabling quicker regulatory submissions.
