ORCHESTRATE PV

EVERSANA ORCHESTRATE PV is an AI-driven, expert-led digital solution designed to streamline the entire drug safety life cycle. It aims to deliver faster, more accurate outcomes at a reduced cost within a collaborative environment. The solution features two primary platforms addressing critical challenges in Literature Monitoring and Aggregate Authoring and Reporting, paving the way for simplified pharmacovigilance.

The system is built to be faster, more accurate, affordable, and scalable. It achieves over 99% accuracy in aggregate reporting and an F1 score of 0.92 across more than 150 safety data fields for adverse event tracking. By reducing manual workflow time, it makes pharmacovigilance more scalable and efficient, offering up to 40% cost savings. The platform integrates strategically with leading safety databases such as Oracle Argus Cloud and sources like PubMed, EMBASE, FDA, EMA, and WHO, and is configurable to support global collaboration, accelerating project onboarding by 30%.

EVERSANA ORCHESTRATE PV enhances workflow efficiency across the safety value chain, accelerating pharmacovigilance operations by 50%. It maintains expert oversight to ensure informed, human-led decisions. Developed with pharmacovigilance experts and industry-tested, the solution applies AI and Generative AI to tackle significant challenges in life sciences, helping clients innovate, reduce risk, and drive sustainable value at scale.

Literature Monitoring Platform

This platform automates the identification of valid adverse events from abstracts and full-text articles, ensuring high data extraction accuracy and reducing manual effort and error risk. It manages the ordering and storage of accepted and rejected full-text articles, addressing challenges such as fragmented vendors, high volumes of multilingual literature, varying global regulatory requirements, and slow, manual data processing.

• Faster: Reduced turnaround time and GenAI-powered summary generation.
• More Accurate: Extraction of over 150 safety data fields with a 0.92 F1 score, 99.8% global submission accuracy, and support for over 100 languages with greater than 90% LLM-driven accuracy.
• Cost Effective: 60% less expensive.
• Seamless Integrations: API integration with databases like EMBASE and system-agnostic integration via R2/R3 based XML support.

Aggregate Authoring and Reporting Platform

This platform streamlines the scheduling of aggregate reporting calendars and the authoring and submission of reports, achieving high accuracy with reduced manual effort. It addresses challenges such as expanding portfolios, inconsistent marketing authorization dates, limited audit trails, and human error.

• Features: Built-in FDA compliant PADER template, capability to sync with safety databases, automated report scheduling, and automated SLA notifications.
• Benefits: Saves 30 minutes per report, 90% reduction in human error, 99%+ accuracy rate, enhanced data traceability, and actionable insights.

Overall, EVERSANA ORCHESTRATE PV reimagines pharmacovigilance with adaptive artificial intelligence that continuously learns and optimizes, offering pre-scheduled and automated aggregate reporting, AI-powered extraction and summarization for adverse event tracking, regulatory-ready reporting and submission, real-time safety signal detection, and seamless navigation and user experience.