Revolutionizing Global Pharmacovigilance at a Top 15 Pharmaceutical Company

8 Jan 2024

Background:

In a groundbreaking collaboration, a leading global pharmaceutical entity joined forces with RxLogix to revolutionize its pharmacovigilance (PV) systems. Recognizing the need for a cohesive, efficient, and globally integrated approach, the company embarked on a transformative project to consolidate its PV operations.

Current State:

The existing PV landscape at the company was intricate, involving over 100 business systems that were labor-intensive and required numerous manual interventions.

Future State Vision:

Under the leadership of RxLogix, the project envisioned a consolidated PV platform with automated data ingestion and streamlined processes. The initiative aimed to automate and streamline a significant portion of case intake steps, harnessing cutting-edge technologies such as Artificial Intelligence (AI) and Machine Learning (ML). The vision included a robust data review mechanism with embedded intelligence for signal detection and management.

Key Changes Envisioned:

Case Intake & Processing, Aggregate & Ad-hoc Reporting, Signal detection & management & Risk Management

• Automated case assignment and data entry.
• Implementation of electronic follow-up mechanisms.
• Integration of workflow and quality oversight features.
• Routine automation of expedited reporting submissions.
• Envisioned Reduction: Up to 75% in manual tasks.

Signal Management:

• Centralized storage and retrieval of data sources.
• Adoption of PV Signal as the primary system for signal detection and management.
• Reduction of tech tools for Signal Detection and Management (SDM) from over 30 to a single system.
• Incorporation of SMART/built-in intelligence for setting thresholds and configuring alerts.
• Envisioned Reduction: ~25% of processes automated/eliminated.

Periodic and Adhoc Reporting:

• Auto-generation of all required data reports for Periodics globally.
• Introduction of self-service reporting for select reports and users.
• Implementation of enhanced governance, oversight, and control over data reports and visualizations.
• Creation of a consolidated library of queries, templates, and reports.
• Envisioned Reduction: ~60% reduction in manual tasks.

Risk Mitigation:

• To ensure a seamless transition, the company identified key risks, including translational capabilities, geographic restrictions on data exchange, integration changes, and the effectiveness of AI/ML models in case processing.

Impact of Future State:

The future state promised a substantial reduction in tasks, direct affiliate and partner access, significant automation, and an enhanced library of queries and reports. The streamlined processes aimed at a significant 60% reduction in tasks and bolstered governance and metrics.

Conclusion:

The pursuit of a unified global PV platform improves operational efficiency, ensures data integrity, and upholds compliance standards. The changes in case management, signal detection, and reporting processes set the stage for a harmonized, automated, and globally integrated pharmacovigilance system, positioning the company as a pioneer in drug safety innovation. The company remains vigilant in addressing potential risks, demonstrating a commitment to a successful transition and the realization of the envisioned future state.

For more information, or to book a demonstration, please reach out to sales@rxlogix.com