The Client Need
The client, a mid-tier biotechnology company with products in a range of therapeutic areas, was struggling with an all-too-familiar challenge: How to effectively collect, organize, triage and archive the large volume of inbound potential AE (Adverse Event) and ADR (Adverse Drug Reaction) reports they received for case processing and reporting.
Pharmacovigilance departments are inundated with adverse event reports from multiple sources using a variety of differing communication mediums and formats. To ensure patient safety, life sciences companies are mandated by the regulatory authorities to maintain and track all the information related to adverse events, including follow-ups and potential duplicates with full traceability to support regulatory inspection. As such, all inbound information received needs to be triaged to determine if there is a valid AE report that requires processing or if additional information is required.
Typically, companies have handled these triaged documents manually – in Excel spreadsheets or even paper binders. This process is not only painfully slow and resource-intensive but also prone to human error and is not readily auditable.
The Process
The client was using the Oracle Argus safety application to process adverse events, but with no triage capabilities they were struggling to triage and organize source documents effectively. To address this gap in process, ArisGlobal successfully integrated our triage tool agXchange Inbound Receipt and Triage (IRT) with the Argus safety system.
With the implementation of IRT, potential AE reports are received through a variety of mediums – email, call, electronic fax etc., – and converted to source documents automatically. A duplicate search is performed against both the local IRT database and Argus and the system displays a case summary from Argus to enable the correct classification of the case. Core case data entry is performed in IRT before the case is submitted to Argus, where the case is created and routed into the first workflow step. Additional case documents received in IRT are also distributed to Argus and automatically attached to the case.
Deploying a tool such as IRT or agTracker enables companies to retain triage source documents and other information as part of the auditable case record in a 21 CFR 11 compliant solution. Additionally, documenting triage decisions when processing safety information increases an organization’s compliance, while case data entry at the earliest point possible in the workstream allows for greater efficiency.
While the system supports flexible processing to suit specific customer requirements, the client implemented standardized SOPs and associated workflow steps for processing new cases and follow-ups. Where partial information is received, IRT supports the generation of queries that are sent to the reporter using the integrated communications module and the case is automatically moved into pending information activity. Any non-AE related documents are classified and archived.
The Results
The seamless integration of the IRT triage tool with the Argus safety system provides the client with a far more efficient system and the ability to document AE reports in an auditable way, ensuring they are ready for inspection. IRT enabled the customer to:
Perform automated duplicate checks and analysis to identify previously reported AE information
Make decisions around information received, such as valid case, invalid, move forward, follow up
Reference in-coming information against safety information already available in the global database and conduct a comparison
Submit reports to the central safety system via the ICH’s E2B standard for transmitting AE reports or ETL (extract, transform, load)
Improve compliance and reconciliation through searchable and exportable correspondence listings, including system-generated emails via configurable business alerts
Maintain and archive all inbound documents, recording triage decisions
Capture the audit trail for case decisions
The next step for the customer is the upgrade to agTracker, the next generation triage tool that provides support for the latest optical character recognition software, E2B R2/R3 [standard/extended] ICSRs, increased case automation, enhanced metrics and reporting to improve efficiency and further reduce case processing time while improving compliance.
Industry Achievement
The process of integrating IRT with the Argus system represents a breakthrough both for the company and the industry, demonstrating ArisGlobal’s flexibility in enabling companies to adopt the best tools for managing all aspects of the safety process, irrespective of the safety management system in place.
The client continues to turn to ArisGlobal for expanded capabilities, with plans to add a call center form to capture information at the point of contact.
