Why MedaSystems’ Platform Sets a New Standard in Expanded Access Program Management
Expanded Access—or compassionate use—is more than a regulatory pathway; it’s often a critical lifeline for patients facing serious or life-threatening conditions. But managing these programs is increasingly complex, involving fragmented systems, evolving regulations, and high-stakes coordination among Medical Affairs, Regulatory, Legal, Supply Chain, Pharmacovigilance, and international affiliates. Many organizations still navigate these through manual, siloed processes—putting patient access, compliance, and operational efficiency at risk.
1. Built from the Ground Up for Expanded Access
At MedaSystems, we’ve intentionally designed our platform with EA in mind—drawing on deep enterprise software industry expertise and real-world operational insights. Rather than retrofitting general-purpose tools, we have spent thousands of hours on user research and today we operate our platform at some of the largest pharma companies across the globe. Our system embeds essential EA workflows, configurable case management, and clinician-facing portals to support streamlined decision-making and patient safety. This ensures that compliance doesn’t just check a box—it’s seamlessly integrated into daily operations.
2. Fast, Compliant, and Configurable
Rapid Program Launch: With pre-built templates and streamlined intake workflows, you can launch an Expanded Access Program in mere weeks—not months.
Configurability at Its Core: Define your own intake forms, SOP-driven workflows, user roles, and approval paths using a no-code interface. MedaSystems lets you adapt swiftly without developers or custom builds.
Regulatory Assurance: Fully compliant with GxP standards like FDA’s 21 CFR Part 11 and EU Annex 11, our cloud-based SaaS platform ensures that documentation, audit trails, and approvals are both secure and traceable.
3. End-to-End Collaboration Across Stakeholders
From the moment a physician submits a request, MedaSystems ensures transparent, centralized coordination:
Physicians submit via a portal that supports structured intake, status tracking, and two-way communication.
Internal teams—Medical Affairs, Regulatory, Supply Chain, Quality—engage through a structured, auditable process, minimizing delays and reducing risk.
Real-time dashboards offer clear visibility into program status, bottlenecks, and compliance metrics, empowering leadership with actionable insights.
4. Real-World Data (RWD) Capture & Insights
MedaSystems isn’t just about access—it’s about learning:
Use our flexible forms to capture safety signals, outcomes, and other RWD during EA delivery.
Whether for internal strategy or regulatory engagement, these insights help BioPharma companies make more informed, faster decisions—even ahead of commercialization.
5. Educational Resources and Expert Guidance
MedaSystems goes beyond technology to support capability building:
Access comprehensive white papers such as “Expanded Access in the United States: Planning and Management Considerations,” or strategic guides like “BUILD vs BUY: 5 Reasons to Choose MedaSystems Over Building In-House.”
Our blog series—spanning topics from philosophical considerations to operational checklists—provides a real-world playbook for EA program leaders.
6. Proven, Forward-Looking Capability
MedaSystems is actively shaping the conversation—featured at the 2024 Operationalize Expanded Access Show and the Society for Neuro-Oncology Annual Meeting—with active development of advanced automation tools like reminders and workflow enhancements.
Our innovation roadmap includes deeper automation, predictive insights, and improved operational efficiency.
Managing Expanded Access doesn’t have to be a manual, fragmented and difficult experience. With MedaSystems, your EA programs become efficient, compliant, collaborative—and positioned for long-term strategic impact.
Want support accelerating patient access, capturing real-world insights, and streamlining EA operations globally? Get in touch with us today to explore a tailored demonstration of how MedaSystems can elevate your Expanded Access strategy.
