P238: Harnessing Advanced Analytics: Automation of PBRER Summaries to Elevate Analytical Rigor and Decision-Making
Poster Presenter
Sahith Doppalapudi
Associate Director, PV Analytics Analytics Center of Excellence
Bristol Myers Squibb United States
Objectives
Automating PBRER summary preparation transforms a labor-intensive process by reducing manual data handling and integrating advanced analytics. This initiative enhances operational efficiency, enabling teams to focus on strategic analysis and informed decision-making, improving productivity.
Method
The process entailed harmonizing the PBRER template across therapeutic areas, precisely defining relevant sections, data elements, and population logic in collaboration with Safety, Medical Writing, and Regulatory teams. Additionally, the current ecosystem was evaluated to minimize user disruption
Results
All requisite data points necessary for the preparation of PBRER summaries were meticulously identified through a comprehensive review of regulatory and organizational reporting requirements. This rigorous process ensured that every relevant element was captured, regardless of therapeutic area, thereby establishing a robust foundation for subsequent automation.
A sophisticated algorithm was developed to facilitate the extraction of these data points from the corporate safety database, leveraging advanced analytics to ensure both accuracy and consistency across therapeutic areas. The logic underpinning the calculations required for the summaries was thoughtfully implemented within the semantic layer, automating complex data processing tasks and significantly reducing the need for manual intervention. This approach not only streamlined the workflow but also enhanced the reliability and reproducibility of the summary preparation process.
To further optimize user experience, the interface was designed to prompt users for key parameters such as date range and asset name, enabling the seamless generation of tailored summaries.
The interface and its underlying processes were subjected to rigorous validation to ensure full compliance with GxP regulations. Comprehensive testing and documentation were conducted, and relevant internal procedures were revised to reflect these updates, thereby maintaining alignment with regulatory standards and organizational best practices.
Upon deployment, end users were invited to participate in a survey following their engagement with the new interface for summary preparation. The feedback collected was overwhelmingly positive, highlighting significant improvements in usability, efficiency, and overall satisfaction with the enhanced process. This response underscored the value of the innovation and its impact on operational excellence
Conclusion
The implementation of this innovative solution has catalyzed a profound transformation in operational efficiency throughout the organization. By reengineering the process for authoring PBRER summaries, the solution has markedly reduced the time and effort required across multiple functional teams. Historically, the preparation of these summaries was a highly labor-intensive endeavor, often consuming several hours and necessitating extensive manual manipulation of data, including the use of disparate spreadsheets and intricate pivot table verifications. The deployment of the new interface has accelerated this process to mere minutes, yielding a substantial reduction in workload and an estimated annual time savings of approximately 1,000 hours.
Central to the success of this initiative was the strategic enhancement of the existing ecosystem. Rather than introducing entirely new platforms or incurring significant expenditures, the solution was architected to leverage and augment the current technological infrastructure. This approach ensured seamless integration with established workflows, minimized user disruption, and delivered exceptional value at minimal cost. By optimizing and extending the capabilities of the existing ecosystem, the organization was able to achieve operational excellence without compromising continuity.
The resultant efficiency gains have not only alleviated administrative burdens but have also empowered teams to redirect their focus toward higher-value, strategic activities. The automation of previously manual processes has significantly mitigated the risk of human error and enhanced data integrity, thereby elevating the overall quality and reliability of deliverables. Moreover, the solution has fostered enhanced collaboration and synergy among Safety, Regulatory, and Medical Writing teams, facilitating more seamless communication and coordination.
