Adverse Event Processing with a Compliant Database

Client Challenge
A global CRO company was struggling with the high volume of adverse event (AE) reports for its product portfolio. The existing system for processing AEs was inefficient, leading to delays in reporting, inconsistent data quality, and potential regulatory non-compliance. The client needed a solution to streamline AE processing while ensuring compliance with global pharmacovigilance regulations.

PVigi’s Solution
PVigi implemented an Efficient Adverse Event Processing System powered by a compliant and robust database. Our approach included:

Database Implementation

Streamlined AE Processing

Data Quality and Consistency

Regulatory Compliance

Training and Support

Outcome
Faster Processing Times: AE reports were processed and submitted 50% faster, reducing the risk of regulatory penalties.

Improved Data Quality: The compliant database ensured high-quality, consistent, and accurate AE data.

Regulatory Compliance: The client achieved full compliance with global pharmacovigilance regulations, including timely ICSR submissions.

Enhanced Efficiency: The streamlined system reduced manual workload, allowing the client’s team to focus on higher-value activities.

Scalability: The system was scalable to accommodate future growth in the client’s product portfolio.