Our techno-functional experts shall help manage your Pharmacovigilance activities Proactively and Strategically by providing dynamic, visual, data-mining technology solutions for detecting signals, uncovering patterns, and recognizing trends in spontaneous adverse event report and data in clinical research studies.
- Empirica Signal: Enable identification and monitoring of safety trends using the same tools used by regulators. Prioritize and execute critical pharmacovigilance activities, analyze both drug/event combinations and drug/drug interactions. Help detect problems that may have been overlooked during clinical development and filter out false positives to focus on the most important risks
- Empirica Study: Provides easy access to clinical trials safety data, simplifies pooling of data and provides greater visibility into clinical data
Topics: Facilitates collaboration, improves senior management visibility, increases the ability to respond quickly to regulatory inquiries, supports proactive lifecycle risk management and enables streamlined implementation.
Our Pharmacovigilance techno-functional consultants understand your business challenges and provide various expert services on the Empirica platform:
- Solution design activities including business/functional requirement analysis, solution strategy, solution design and selection
- System integration services using accelerators to deliver implementation, validation, upgrade, project management, data/systems migration, end user training
- Custom ETL development
- Fully managed regulatory compliant cloud hosting
- Service desk and application support
- Design and development of custom reports using OBIEE and other BI platforms, mobile apps etc.
All our early phase clinic automation services utilize our Optimized Global Service Delivery Model designed to make you fully compliant with regulatory requirements and industry standards.