Clinical Study Reports

Axtria Harnesses GenAI to Slash Timelines and Boost Accuracy in Clinical Study Reporting with Axtria Rapid CSR


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 leader in cloud software and data analytics 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. Watch a short video here.

  • 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.

About Axtria’s Clinical Solutions:

Axtria’s Clinical Solutions practice area drives value realization for life sciences companies through groundbreaking clinical innovations and measurable results. Our expertise lies in solving complex challenges in life sciences research and development through cutting-edge data science, generative AI, and advanced information management solutions. We specialize in modernizing clinical data workflows, enhancing clinical program management, and running late-phase investigations, leveraging proprietary technology accelerators to deliver measurable improvements in efficiency and quality. Our team is dedicated to supporting clinical research and trials with tailored solutions, robust analytics, and seamless execution to address the most pressing needs in the industry.

About Axtria's Products and Solutions

Axtria is the market leader in agentic-AI powered products and services for the life sciences industry. Our cloud solutions and domain-trained agents help organizations accelerate commercialization, enhance decision-making, and deliver measurable business impact across the value chain. We deliver value through an integrated approach that combines deep domain expertise and strategic consulting with our AI-native cloud software suite. Our Agentic AI portfolio empowers life sciences organizations to accelerate innovation and make smarter, faster decisions. Axtria InsightsMAx.ai serves as the enterprise-grade platform that unites intelligence, automation, and orchestration across the commercialization journey. Axtria SalesIQ™ drives field force and provider effectiveness with embedded AI insights, Axtria CustomerIQ™ orchestrates personalized experiences through next-best-action intelligence, Axtria MarketingIQ™transforms commercial investments into precision strategies, and Axtria DataMAx™ provides the secure, trusted data foundation that powers every AI and Agentic AI transformation.

Contact Information

Anjali Kumari
Axtria, Inc.
anjali.kumari1@axtria.com

About Axtria

Axtria helps life sciences companies harness the potential of data science and software to improve patient outcomes by connecting the right therapies to the right patients at the right time. The company is a leading global provider of award-winning cloud software and data analytics to the life sciences industry. We’re proud to deliver proven solutions that help pharmaceutical, medical device, and diagnostics companies complete their journey from data to insights to action, enabling them to earn superior returns on their investments. As a participant in the United Nations Global Compact, Axtria is committed to aligning strategies and operations with universal principles on human rights, labor, environment, and anti-corruption, and taking actions that advance societal goals. For more information, please visit www.axtria.com.