Local Literature Review for Signal Detection

Client Challenge

A pharmaceutical company approached PVigi with concerns about potential safety signals for one of their marketed products. The client needed to monitor both local and global literature to identify emerging safety concerns and ensure compliance with regulatory requirements. However, they lacked the resources and expertise to conduct a systematic and comprehensive literature review.

Our Solution

PVigi implemented a Comprehensive Local Literature Review for Signal Detection to address the client’s needs. Our approach included:

1. Systematic Literature Search
2. Data Extraction and Analysis
3. Regulatory Compliance
4. Proactive Risk Mitigation

Outcome

• Early Signal Detection: PVigi identified potential safety signals early, allowing the client to take proactive measures.
• Regulatory Compliance: The client met all regulatory requirements for literature monitoring and reporting.
• Enhanced Safety Profile: The client’s product safety profile was strengthened, ensuring continued market authorization.
• Client Satisfaction: The client praised PVigi’s expertise and efficiency, leading to a long-term partnership.