Authenticx Expands Pharmacovigilance AI to Automate Downstream Safety Workflows With Accuracy
New capabilities build on Authenticx's established adverse event detection technology, connecting patient conversations with pharmaceutical manufacturers' existing safety workflows
The solution analyzes interactions between pharmaceutical manufacturers' patient services teams and the patients and providers they serve, including self-service chats and bots as well as calls routed through contact centers and hubs. It flags potential safety events across configured interactions, structures relevant conversation details and metadata for review and preserves transcript context. Manufacturers can configure a human checkpoint within Authenticx or route the record into their system of record for review. Trained pharmacovigilance professionals retain responsibility for case qualification, reportability determinations and regulatory submissions.
Potential safety events often surface during routine patient-service conversations. Once a signal is identified, relevant details must be located, documented and routed across contact center, patient services and pharmacovigilance teams. Manual review, data entry and handoffs can add time and inconsistency to regulated workflows. Federal regulations require applicants to promptly review adverse drug experience information received from any source, with serious and unexpected adverse drug experiences generally reportable within 15 calendar days of receipt.
Authenticx introduced its safety-event AI in 2024 to identify potential adverse events, product quality complaints and special situations in patient interactions, highlight relevant transcript language and route conversations for review. The expanded capabilities carry more of that work forward after detection, helping move the context from the original conversation into the manufacturer's established safety workflow.
"PV teams are not looking to remove human judgment from a regulated workflow. They need to reduce the manual work that delays it," said
The expanded workflow includes:
- AI-assisted form population: Authenticx detects a potential safety signal and pre-populates a configurable pharmacovigilance form using relevant conversation details and metadata.
- Configurable human oversight: Manufacturers can apply client-defined review standards across configured interactions and place a human qualification checkpoint where it fits their governance requirements.
- System-of-record delivery: Once validated, records can be routed into Oracle Argus, Veeva, Salesforce or another configured system of record, reducing manual re-entry and preserving the source context for reviewers.
Authenticx's established safety-event detection and review technology has already demonstrated measurable impact. In a published case study involving chatbot and voicebot interactions at a global pharmaceutical manufacturer, supervised AI reduced manual adverse event and product complaint review by approximately 90 percent and achieved 99 percent accuracy across more than 372,000 interactions. The customer has since expanded its use of Authenticx to include these capabilities.
The expanded capabilities are available now. Learn more at authenticx.com/product/safety-compliance.
About Authenticx
Authenticx, founded in 2018 by Amy Brown, is the system-critical conversation intelligence platform built exclusively for healthcare. Authenticx analyzes recorded calls, emails, chats and other interactions using healthcare-trained AI to uncover what matters most across safety, compliance and the patient and member experience. By transforming unstructured conversations into clear, actionable insight, Authenticx gives enterprise healthcare leaders the operational clarity they need to reduce inefficiencies, strengthen compliance and improve experiences at scale.
Media Contact
Molly Connor
317-903-8111
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SOURCE Authenticx
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