Solution Spotlight: Axtria Rapid CSR
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.
What problem or status quo deficiency are you solving?
Creating clinical study reports (CSRs) has traditionally been a complex and time-consuming process. Pharmaceutical companies rely on medical writers, who manually craft these reports using numerous input files across a multitude of formats. Axtria Rapid CSR, an advanced and innovative solution, transforms CSR generation. Powered by cutting edge GenAI, Axtria Rapid CSR delivers CSRs with 30%–50% faster turnarounds, 90% ICH-E3-aligned accuracy, and substantial cost savings.
What has made this problem challenging to address in the past?
CSRs provide comprehensive summaries of clinical trials, detailing the critical elements of study design, endpoints, methodologies, results, and conclusions. The creation of CSRs involves 16 distinct sections, requiring months of collaboration among various stakeholders, who must analyse vast amounts of complex study data to develop customised summaries.
What new innovations does your solution bring to bear on these challenges?
CSRs can now be done better, faster, and more cost effectively. Axtria Rapid CSR provides a bold breakthrough in the CSR authoring process. This innovative solution is predicated on a multi-LLM approach, capable of automating the first-draft creation of even the most comprehensive CSRs.
Watch a short video here.
How does your solution work?
Axtria Rapid CSR utilises GenAI for the processing and automation of clinical study report development. It has been trained and tested to reduce the generation of these reports by 30%–50% for most large-scale phase III clinical trials.
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, summarising 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.
What makes your solution stand out in the market?
Axtria Rapid CSR is capable of supporting studies of all sizes, from early-phase trials to post-surveillance. Watch a short video here.
Axtria Rapid CSR doesn’t just automate, it’s smart. It draws critical inferences from multiple study data inputs, providing deeper context and relevance, even for the most complex sections of a report. Axtria Rapid CSR significantly advances the industry’s ability to generate accurate medical writing, particularly in safety and efficacy.
Axtria’s Clinical Solutions practice area drives value realisation 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 specialise in modernising clinical data workflows, enhancing clinical programme 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.
What concrete outcomes and KPI benefits does your solution convey?
“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,” comments 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,” he adds.
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.
How does your solution improve the experience for the end user?
We believe CSR authoring will never be the same. It combines the power of artificial intelligence with human expertise to deliver superior results, eliminating tedious efforts for clinical researchers and medical writers. Axtria Rapid CSR gives them the freedom to spend their time searching for revelations, not repetition. 30%–50% faster turnarounds mean substantial cost savings for life sciences companies. 90% ICH-E3-aligned accuracy can mean quicker regulatory approvals. And that helps get the latest life-changing medications to the patients who need them most – at the right time.
Reach out to us at axtria_clinicalsolutions@axtria.com for a one-on-one demonstration. You’ll see how Axtria Rapid CSR modernises your clinical study report process, giving you faster approvals, cutting costs, and improving more lives.
About the author
Luke Dunlap is Principal and Head of Clinical Solutions at Axtria Inc. For nearly 30 years, Dunlap has led life sciences and healthcare practices, serving the world’s largest pharmaceutical companies across research and development, mergers and acquisitions, and clinical development. At Axtria, Dunlap leads the Clinical Solutions practice, focusing on the enablement of EMR to EDC automation, clinical data workflows, analytics, and reporting. Through Dunlap’s leadership, the Axtria Clinical Solutions team enables ML and GenAI acceleration of clinical study reports and data capture, driving core efficiencies into the clinical development process. Dunlap’s work improves quality and delivers data-driven insights for critical clinical trials.
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.
