Literature Monitoring & Aggregate Authoring
Simplifying the PV Process
EVERSANA ORCHESTRATETM PV
The AI-powered, expert-led digital solution that streamlines the entire drug safety life cycle for faster, more accurate outcomes at lower cost—all in one collaborative environment.
Featuring two product platforms designed to solve the most critical challenges in Literature Monitoring and Aggregate Authoring and Reporting, ORCHESTRATE PV delivers the future of simplified pharmacovigilance.
Built and Integrated With
Faster. Accurate. Affordable. Scalable.
Improved Accuracy
Delivers +99% accuracy in aggregate reporting and achieves an F1 score of 0.92 across 150+ safety data fields for adverse event tracking.
Reduced Cost
Reduces manual workflow time and burden making pharmacovigilance more scalable, efficient and less resource-intensive, delivering up to 40% in cost savings.
Strategic Integrations
Connects with leading safety databases like Oracle Argus Cloud and sources such as PubMed, EMBASE, FDA, EMA, and WHO.
Increased Scalability
Configurable to support global collaboration and accelerate project onboarding by 30%.
Accelerated Workflows
Boosts efficiencies across the safety value chain to accelerate the PV operations life cycle by 50%.
Expert Oversight
Maintains expert oversight for informed, human-led decisions.
Developed with PV Experts & Industry-Tested
Discover the Platforms Comprising ORCHESTRATE PV
Literature Monitoring Platform
About the Platform
The Literature Monitoring Platform Automates the identification of valid adverse events from abstracts and full-text articles, tracks them with high data extraction accuracy, and significantly reduces manual effort and error risk. It also manages the ordering and storage of accepted and rejected full-text articles.
Challenges the Platform Solves
- Fragmented vendors
- High volume of multi-lingual literature
- Varying global regulatory requirements
- Slow, manual data processing
Features and Benefits
Faster
- Reduced turnaround time
- Day 0 readiness
- GenAI-powered summary generation
More Accurate
- Extraction of 150+ safety data fields with .92 F1 score
- 99.8% global submission accuracy
- 100% inspection readiness with zero critical and major findings
- 100+ language support with >90% LLM-driven accuracy
Cost Effective
- 60% less expensive
Seamless Integrations and Custom Workflows
- API integration providing direct access to databases like EMBASE
- System agnostic integration via R2/R3 based XML support
- Custom workflows based on organizational needs
Aggregate Authoring and Reporting Platform
About the Platform
The Aggregate Authoring and Reporting Platform streamlines the scheduling of aggregate reporting calendars, as well as the authoring and submission of reports, with high accuracy and reduced manual effort.
Challenges the Platform Solves
- Expanding portfolios
- Inconsistent Marketing Authorization dates and reporting timelines
- Limited audit trails
- Human error
Features and Benefits
Features
- Built-in FDA compliant PADER template
- Capability to sync with safety database
to generate narratives for PADER reports - Automated report scheduling
- Automated assessment and narrative generation
- Automated SLA notifications
- Aggregate action board
Benefits
- Faster
- Saves 30 minutes per report
- More Accurate
- 90% reduction in human error
- 99%+ accuracy rate
- Enhanced data traceability
- Actionable insights
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