Five Years of MedaSystems: How Expanded Access Is Evolving—and What Comes Next

Five years ago, MedaSystems was founded around a straightforward idea: there had to be a better way for life sciences organizations to manage Expanded Access.

At the time, many Expanded Access programs still depended heavily on spreadsheets, email, repurposed systems, and manual processes. For teams navigating different regulatory requirements across countries while responding to physicians seeking treatment for patients with serious or life-threatening conditions, those processes created unnecessary complexity.

During our recent five-year anniversary webinar, MedaSystems Co-Founder and EVP Matt Rosen joined the MedaSystems team to reflect on how the industry has changed, how the platform has evolved alongside our customers, and where Expanded Access technology may be headed next.

One thing became clear throughout the conversation: Expanded Access itself is changing. What was once frequently managed as a reactive process is increasingly becoming a strategic, technology-enabled capability.

Why MedaSystems Was Founded

The original opportunity MedaSystems saw wasn't simply to replace spreadsheets.

It was to address the operational complexity that begins once a pharmaceutical company decides to make an investigational therapy available outside a clinical trial.

Teams were managing regulatory requirements that varied by country, tracking requests through emails and spreadsheets, and often lacked visibility into exactly where an individual case stood. At the same time, physicians and patients needed decisions quickly.

MedaSystems saw an opportunity for software to create a more structured and efficient process while also making it possible to capture information generated during treatment without unnecessarily increasing the burden on physicians.

That challenge wasn't limited to large pharmaceutical organizations. MedaSystems saw similar needs among smaller biotechnology companies, particularly as interest in pre-approval access increased across oncology, rare disease, and orphan indications. Regulatory developments and increasing interest in real-world data further reinforced the need for purpose-built technology.

From Reactive Requests to Strategic Programs

One of the most significant changes over the past five years has been the growing strategic importance of Expanded Access.

Organizations are increasingly thinking about pre-approval access earlier in the product lifecycle rather than waiting until requests begin arriving.

That means establishing policies and SOPs, defining responsibilities across functions, considering supply and ethical implications, and determining how programs can be supported operationally as request volumes grow.

As Matt explained during the webinar, this shift has been underway at large pharmaceutical organizations for some time but is becoming more widespread across the industry, particularly in oncology and rare disease.

For program teams, that evolution creates a new question: Does the operational infrastructure supporting Expanded Access match its growing strategic importance?

As programs become more global and complex, relying exclusively on manual processes becomes increasingly difficult to scale.

Making Expanded Access Faster Through Automation

One of the clearest examples of how technology can change Expanded Access operations is automation.

During the webinar demonstration, the MedaSystems team showed how incoming cases can automatically be routed to the appropriate workflow based on configurable rules.

Instead of requiring a case processor to manually review an incoming request and determine where it should go, automation can apply the appropriate workflow, assign the case, and add relevant team members.

The result is less administrative orchestration and a process designed to keep requests moving.

The demonstration also highlighted MedaSystems' Teams functionality. Rather than assigning every task to a specific individual, organizations can assign work to a team. Available team members can claim a task, while others are automatically informed that it is being handled.

For global pharmaceutical organizations with country-specific or program-specific teams, these capabilities can help reduce delays caused by availability, handoffs, or manual coordination.

Building the Platform Around Customer Feedback

The MedaSystems platform has changed substantially over five years, and much of that evolution has come directly from customers and users.

During the webinar, the team shared that 94 new features had been delivered during the year at the time of the presentation, spanning everything from major capabilities such as team-based task management to small user-experience improvements.

Those seemingly small improvements matter.

If users repeatedly spend time scrolling through long lists, manually routing requests, or coordinating work through email, those individual inefficiencies can compound across a global program.

MedaSystems' approach has been to continually identify those friction points and determine where software can remove them.

The platform now also includes an integrated feedback mechanism that allows pharmaceutical users and physicians to submit suggestions, report issues, and rate their experience directly within MedaSystems.

Self-Service and Flexibility Are Becoming Essential

Perhaps one of the most important themes from the product demonstration was flexibility.

No two pharmaceutical companies manage Expanded Access exactly the same way—and no two individual cases are necessarily identical.

Organizations may have different SOPs, regulatory interpretations, country requirements, internal approval structures, and data collection needs.

That means technology cannot simply impose a rigid workflow.

MedaSystems has increasingly invested in self-service capabilities that allow customers to adapt the platform to their own operating models. Recent capabilities include configurable forms, improved filtering, tags, automation rules, and increasingly flexible workflow management.

The webinar also provided a preview of MedaSystems' workflow builder, designed to allow customers to modify and publish workflows themselves rather than relying on the MedaSystems team to make every change.

This represents an important evolution in Expanded Access technology: moving beyond simply digitizing an existing process toward giving program teams the tools to continuously optimize it.

Real-World Data Without Creating Additional Burden

Expanded Access is treatment—not research. That distinction remains fundamental.

At the same time, treatment experiences can generate information that may help organizations better understand how therapies are being used outside clinical trials.

The challenge is collecting useful information without placing unnecessary demands on healthcare professionals.

During the demonstration, MedaSystems showed how a short real-world data collection form could be inserted directly into an individual case workflow and assigned to the treating physician. Simple questions and dropdown responses can make participation easier while allowing program teams to capture structured information.

The flexibility to modify workflows in real time is particularly important because opportunities to collect useful information may emerge after a program has already begun.

Rather than attempting to reconstruct that information retrospectively, program teams can adapt the workflow as needs evolve—while maintaining an audit trail documenting what changed, when it changed, and who made the change.

The Next Evolution: AI Meets the Regulatory Source of Truth

The webinar also looked beyond today's platform capabilities toward the potential role of AI.

Rather than attempting to create a proprietary AI model that customers must use, MedaSystems discussed a different vision: maintaining the validated platform as the regulatory source of truth while enabling organizations to securely use enterprise AI tools approved by their own IT teams to analyze authorized data.

One technology that could help make that possible is Model Context Protocol (MCP).

As discussed during the webinar, MCP can provide a standardized way for approved AI systems to interact with enterprise data while respecting the permissions associated with individual users.

For Expanded Access teams, the possibilities could eventually include analyzing program data, identifying workflow bottlenecks, creating reports, exploring outcomes data, and generating operational insights through conversational AI tools.

Importantly, the underlying regulated system and its controls remain essential. AI may accelerate analysis and software development, but regulated environments still require rigorous documentation, testing, validation, and appropriate access controls.

What Will Expanded Access Look Like Five Years From Now?

Looking ahead, Matt offered a comparison to clinical trials.

Today, it would be difficult to imagine running a large Phase III clinical trial entirely through paper records—not necessarily because paper itself is prohibited, but because technology has become fundamental to operating efficiently at that scale.

Expanded Access may be heading in a similar direction.

As programs become more strategic, global, data-driven, and operationally complex, a dedicated technology layer could increasingly become an expected part of program infrastructure.

That technology is also likely to become more intelligent.

Automation can already route requests and coordinate work. Over time, AI may help teams analyze program performance, identify bottlenecks, surface insights, and potentially support more aspects of operational decision-making.

Preparing for the Next Five Years

For organizations thinking about the future of Expanded Access, the takeaway from the webinar was not simply to adopt more technology.

It was to think about where technology is going.

Organizations developing Expanded Access strategies today should consider how their processes will accommodate greater automation, configurable workflows, structured data collection, validated systems, and emerging AI capabilities.

And those conversations should begin early.

As the MedaSystems team emphasized at the conclusion of the webinar, organizations still relying on paper or highly manual processes should begin considering the technology infrastructure that will support Expanded Access as programs evolve. Even organizations early in development can incorporate technology considerations alongside the policies and SOPs they will eventually need.

Five years after MedaSystems was founded, the industry has come a long way.

The next five years may bring an even bigger transformation—from digitizing Expanded Access processes to creating connected, automated, intelligent infrastructure that helps pharmaceutical companies operate programs more efficiently while keeping the needs of physicians and patients at the center.