Conduent Applies GenAI to Revolutionize Detection of Reportable Events and Sets New Standard for FDA Compliance
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Why It Matters
Pharma and Life Science companies handle countless interactions with customers every day via emails, chats, voice calls, texts, faxes, and social and digital platforms, and within these interactions is vital information that potentially must be reported to the FDA.
Real-world examples of reportable events
- A patient emailing about unexpected dizziness after taking a prescribed medication.
- A caregiver calling to report a child’s rash after using a topical cream.
- A customer texting that their insulin pen malfunctioned during use.
- A chatbot conversation revealing confusion over dosage instructions.
- A social media post describing a broken inhaler or packaging defect.
Setting New Standard for Compliance
Quality control to ensure the highest standards of quality, accuracy, and compliance are met is typically a manual process that can only randomly evaluate a small percentage of customer interactions. This new GenAI-powered solution can review nearly 100% of interactions across all channels, using GenAI to analyze language, context, and compliance rules to revolutionize the identification of reportable events.
"Patient assistance programs and medical information engagements are complex and data-rich, which is perfect for GenAI,” said
This solution integrates GenAI with logical reasoning, AI-driven search, client-specific rules, training materials, and regulatory framework, backed by Conduent’s infrastructure, to automate the capture and classification of reportable events.
Key Benefits:
- Enhanced Efficiency: Streamlines the process of identifying reportable events, saving time and reducing manual efforts.
- Quality and Consistency: Understands the variability of consumer language to better identify potential reportable events and product quality complaints, and provides consistent, high-quality reporting.
- Regulatory Compliance: Enables adherence to FDA regulations and other compliance standards, minimizing the risk of penalties. Life Science companies can use the data to enhance their marketing strategies, product packaging and user experiences while ensuring compliance with FDA regulations.
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