Pharmacovigilance adverse event data entry and management for high case volume poses a resourcing challenge, especially regarding the completion of repetitive administrative tasks – such as tracking & triaging incoming emails in the safety mailbox, requesting translation of source documents, data entry & uploading source documents into the safety database, and reconciling received emails – all at the speed of human interaction. These tasks take up the precious bandwidth of highly qualified PV experts who should instead utilize their time and specialized experience on scientific activities (e.g. case assessment, quality control, etc).
To help our clients more easily manage and navigate their case processing needs, in 2020, UBC deployed a powerful custom-developed case processing automation platform that provides a real-time, intuitive, and scalable solution designed to increase the efficiency, speed, and quality of high-volume case processing while maintaining regulatory compliance.
Our PV case automation platform features:
- Mailbox Management: Automated 24/7 handling of incoming emails containing source documents and automated email acknowledgement
- Automated Case Intake: Automation algorithms map the safety report form into the standard E2B R3 format and then into Argus for automated duplicate check and case creation, including filing of source documents in the safety database
- Translation Management: Preparation of documents for translation that is integrated with UBC’s certified translation vendor processes
- Email Reconciliation: Verification and reconciliation of the emails received that do not contain source documents
- Work Assignment: Automated case assignment based on individual team member availability and location
The efficiency of this automation platform is higher if the source document formats are harmonized across different reporting sources as much as possible, and align with ICH E2B requirements, to ensure better mapping with the safety database fields. The target is to automate 85% – 90% of cases received.
With this level of automation and robust algorithms, case management time is significantly reduced as the case specialist will only have to provide input for missing and un-readable values, reducing the incidence of human error. The system manages data entry consistency, which increases case quality and allows PV experts to focus on specialized activities. This ultimately helps our clients manage their PV budget, despite the case volume increase.
Unlike many off-the-shelf software solutions that attempt to be a one-size-fits-all case management, UBC’s PV case automation platform is purpose-built with a focus on customizing our technology for your specific product and program needs.
ABOUT UBC:
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Our combined scientific expertise in pharmacovigilance, risk management, and signal detection and assessment, underpinned by innovative technologies, offer our customers customized solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.
ABOUT THE AUTHOR:
Helena Pedrosa, PharmD, PhD, Associate Director, Global Case Processing, Pharmacovigilance
Dr. Pedrosa joined UBC in October 2012 and has 11 years of experience in the pharmaceutical industry. She acquired experience at UBC as a Safety Data Associate, Safety Scientist and Team Manager for multiple clients. Dr. Pedrosa has a proven record in end-to-end case processing of clinical trial and post-marketing cases (including managing large case processing volumes using case intake automation) and regulatory compliance and is a subject matter expert for scientific literature monitoring for PV. She currently manages several operational teams performing case processing, expedited reporting, literature monitoring, safety database configurations and output requests, reconciliation activities, and local PV activities. She holds a Pharm D and a PhD in Toxicology from University of Porto (Portugal).
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