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P40: Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of Aggregate Reports

Poster Presenter

      Jennifer Cichone

      • Director, GPV Strategic Management Office


Our research aimed to enhance the efficiency and cost-effectiveness of authoring the aggregate reports by an electronic aggregate report authoring tool - Automated Document Reporting [aDocR]. This computer-programmed collaboration tool auto-populates reports by extracting source data and templates.


The aDocR platform has a document generating framework, performing granular predefined mapping of source data and templates. Report generation occurs dynamically by applying natural language processing, employing machine learning, and using algorithms.


The aDocR platform is an innovative tool that prepares reports, which involve data-driven generation of textual content development, and its reuse across various target reports, using natural language processing. The effectiveness of the aDocR platform was measured by authoring three types of aggregate reports—Periodic Adverse Drug Experience Report (PADER); Suspected Unexpected Serious Adverse Reaction (SUSAR); and Serious Adverse Reaction (SAR) between Dec 2018 and Dec 2020. 50 aggregate reports were generated by the automated program during the above-mentioned time period. Each section of the PADER and SUSAR/SAR reports was completely automated. The aDocR platform was used to author a total of 23 PADER reports, which led to an average effort saving of 41 hours per PADER, corresponding to an 83.6% savings in authoring efforts. Time savings ranged from 20 hours to 74 hours depending on low to high complexity of reports. The total effort savings was 936.5 hours for 23 PADER reports authored, using the automated tool from a period of Dec 2018 to Dec 2020, with an estimated cost savings of $140,475. The estimated cost savings were $1500 per report and $40,500 (for 27 SUSAR/SAR reports) between Dec 2018 to Dec 2020. Accurate data capture occurred in all the PADER, SUSAR, and SAR reports authored using aDocR. The use of templates and structured data sources are critical requirements for success of this aDocR tool, to ensure high compliance. Overall the quality of these automated reports was higher than manually prepared reports.


Automation in pharmacovigilance (PV) has been discussed frequently, and while a significant amount of research is being conducted in this area for diverse domains of PV, there has not been much progress associated with the automation of aggregate reports. Given that the generation of aggregate reports are costly, time-consuming, and resource-intensive, along with requiring effective communication and cross-collaboration amidst different functional stakeholders in organizations, automation offers the promise of efficiency and cost-effectiveness. Currently, aDocR offers a distinctive platform that presents incredible opportunities for the company and potentially for the industry. The aDocR platform is a sophisticated and cost-effective option to reduce resource utilization and time consumption for the authoring of aggregate reports. Use of the aDocR platform for report generation allowed accurate capture of data in the corresponding sections of the report templates, which ensured high compliance and quality. Additionally, the automation platform allowed the teams to focus on content-driven analyses. Further enhancement of the platform will introduce scalability and efficiency in the operations. Collaborating with cross-functional teams that contribute to the authoring of aggregate and other safety reports, along with identifying data sources for aDocR, will aid in structuring the authoring process, making it simpler than the manual authoring process. The successful generation of PADER, SUSAR, and SAR reports using this aDocR platform encouraged us to employ it to automate the authoring of other complex aggregate reports, such as the Development Safety Update Report (DSUR) and the Periodic Safety Update Report (PSUR). Eventually, we expect that the usage of this tool can be expanded to author other safety reports such as Risk Management Plans and Clinical Overviews, along with other quality and regulatory reports.