Developing a cost-effective and efficient safety case management solution for data coordinating center projects

Abstract

A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA. During the software's tenure, we experienced incompatibilities with other clinical research software resulting in unanticipated inefficiencies. Furthermore, the small number of periodic and suspected unexpected serious adverse reaction (SUSAR) cases rendered the annual license fee not cost-effective. An internal analysis of our workflow, systems, and processes revealed that developing a cost-effective and efficient customized solution for our existing data coordinating center (DCC) projects was feasible. The customized solution mimics the key functionality and workflow of the prior software. It utilizes existing electronic data capture systems and document management solutions, ensuring 21 CFR Part 11 compliance without incurring additional expenses. The proposed process received internal approval and launched in December 2022. The process outlined in this paper is particularly advantageous for DCCs or academic clinical research sites that must meet regulatory reporting requirements without depending on specialized pharmacovigilance software. Additionally, it is a cost-effective option for organizations with a low volume of SUSAR events. In this paper, we present the process of developing and implementing a customized safety case management solution and the lessons learned pre and post implementation.