Enterprise Pharmaceutical Case Study
Revolutionizing Global Expanded Access
Client Profile
Summary
See how a top pharmaceutical company is revolutionizing its operations by partnering with MedaSystems. This collaboration sets a new standard for managing global Expanded Access Programs (EAPs). Through innovation and strategic implementation, MedaSystems is helping the company fulfill its mission of improving patient access globally.
The Challenge
A leading global pharmaceutical company known for its pipeline of potentially life-saving products faced significant operational challenges in handling pre-approval access to investigational medicines for patients in need outside of clinical trials. With thousands of healthcare provider requests pouring in from more than 60 countries, their existing systems—a mix of outdated tools and manual processes—were proving inadequate. The inability to efficiently manage these requests and deliver life-saving treatments created substantial operational, reputational, and regulatory risks. The company’s reliance on fragmented systems led to several critical issues:
Inefficiencies: Outdated tools and manual processes caused data errors, version control problems, and significant delays in processing requests.
Lack of Visibility: Without a centralized, real-time tracking system, urgent requests often fell through the cracks, frustrating healthcare providers and putting patients at risk.
Global Complexity: Navigating country-specific regulatory requirements exposed the company to compliance risks and made audits stressful.
HCP Frustration: Doctors and nurses were burdened with navigating a labyrinth of manual, email-based processes, detracting from patient care.
The scale of these challenges strained the company’s resources and jeopardized its core mission of delivering timely and effective treatments to patients worldwide. To continue fulfilling this mission, the company needed a transformative solution to unify and modernize its operations worldwide.
The Solution
Recognizing the urgency of the situation, MedaSystems introduced a comprehensive, future-proof platform designed to address every aspect of the company’s challenges. The first step was to unify the company’s processes into a centralized digital platform to consolidate data and streamline operations across numerous countries. The once-disparate tools were replaced with a cohesive system that improved efficiency and provided real-time visibility into every patient request.
MedaSystems introduced robust reporting capabilities, generating real-time analytics and tracking performance metrics. Yet, one of the most impactful changes was inviting healthcare providers to collaborate within MedaSystems’ intuitive portal. This simplified the process for submitting and tracking requests, requesting resupply, and updating patient data. With real-time updates and self-service options, healthcare providers and their staff can now easily navigate complex processes, freeing them from the frustrations of previous manual systems.
Key Technologies and Innovations:
Real-Time Reporting: For the first time, data-driven decision-making based on a clear view of each request’s status is possible.
Workflow and Form Configuration: The platform’s flexible architecture allows the company to tailor workflows and forms to the specific needs of different programs and countries. This ensures that the system can quickly adapt to varying regulatory requirements and operational needs, providing a scalable solution that grows with the company.
AI-Powered, Automated Redaction: The platform’s AI-powered automated redaction tool enables the company to de-identify PHI, ensuring the utmost security and compliance in data handling while saving thousands of hours of manual processing.
Seamless Integration: MedaSystems integrates with the company’s existing systems for single sign-on, electronic signature, and data archiving. This integration maintains data consistency, enhances security, and reduces manual data handling, ensuring that all critical functions work together smoothly and efficiently.
Results
The impact of MedaSystems' solution was immediate and profound. The company is poised to see a significant transformation in its operations, with improvements expected in several key areas:
Enhanced Efficiency: Automating workflows and integrating with internal systems is expected to significantly reduce processing times, speed up patient access, and reduce the administrative burden on staff.
Improved Visibility: With real-time tracking and robust reporting, the company will gain unprecedented visibility into its operations, allowing it to monitor request statuses, identify potential bottlenecks, and make proactive, informed decisions.
Better HCP Experience: The intuitive portal simplifies interactions, gives healthcare providers confidence in the process, and improves their overall experience.
As the company adopts the MedaSystems platform across its global operations, these anticipated outcomes set the stage for a future where Expanded Access Programs are managed with unprecedented efficiency and care. The platform is designed to meet the company’s current needs and evolve with them, ensuring they remain at the forefront of global patient access and regulatory compliance.