Medical Writing and RWE Expert Staff Increased Operational Efficiency
Diversity in clinical trials has gained traction following recent regulatory updates with a focus on patient-centricity and innovation. This case study discusses how our medical writing and real-world evidence (RWE) expert staff using AI technology increased the operational efficiency of health economics and outcomes research (HEOR) and global epidemiology teams. In this complex evidence synthesis project for a top five pharmaceutical company, we helped exceeded timelines for a global diversity automation initiative.
Challenge
A US-based top five pharmaceutical sponsor wanted to rapidly curate key evidence across specific geographies on Focal Segmental Glomerular Sclerosis (FSGS) epidemiology for identifying treatable population.
Key challenges to the completion of an evidence synthesis product included the rare nature of data, strict evidentiary requirements with expectations for accurate estimations, and client time constraints.
Solution
To meet this unique business need, a team of RWE functional experts was deployed. The team was enabled by an AI- based solution that provides evidence-based auto-sorting of records, intuitive natural language processing (NLP) captures, and collaborative document editing with annotation. Finally, practical insights from public health experts, senior HEOR analysts, and epidemiologists were considered.
Outcome
The Catalyst Flex solution delivered Early identification of distinct epidemiological transitions depending on variations in geographies, report development time reduced by ~55% to 15 days, and QC time reduced by 10 hours due to zero false positive retrievals and NLP-extracted epidemiology information.
This provided brand teams and market access teams with a report 8+ weeks ahead of their commercial strategies meeting for target markets and saved them up to 75% of the cost of a standard outsourced report.
Business impact
Our solution proved remarkable efficiency gain and accuracy for rare disease-related data curation, and also motivated the client to deploy it in their Global Epidemiology and Diversity Automation Initiatives to support multiple therapeutic areas.
Catalyst is committed to advancing standards and pushing boundaries in the rapidly evolving evidence synthesis landscape. We do this by enabling our RWE experts with innovative automation solutions and best practices compliant with regulatory and health technology assessment (HTA) needs supporting the design and delivery of better clinical trials.
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