Expanded Access is evolving from a largely reactive process into a strategic, technology-enabled capability. Five years after MedaSystems was founded, we look at how automation, configurable workflows, real-world data, and emerging AI technologies are shaping the future of Expanded Access programs.

Expanded Access Programs help patients with serious or life-threatening conditions access investigational therapies when other treatment options are limited. Discover how MedaSystems helps pharmaceutical and biotechnology organizations centralize, automate and scale Expanded Access programs across patients, therapies and markets worldwide.

As Expanded Access programs become more global and complex, pharmaceutical companies need scalable ways to manage requests, maintain compliance, and support patients faster.

For decades, expanded access has been positioned as a last resort — a pathway reserved for patients who have exhausted all other options and cannot participate in clinical trials.

In a recent FDA warning letter involving investigational distribution practices, the agency cited failures tied to regulatory authorization and documentation requirements. The specific facts are unique to that company, but the broader lesson applies to every emerging biotech developing an investigational product.

See how MedaSystems helps sponsors streamline expanded access with configurable intake forms, automated routing, audited workflows, AI-powered PHI redaction, and a simple HCP portal experience.

Expanded access programs—sometimes called compassionate use—often enter a company’s world unexpectedly. A single request from a physician or patient can quickly become a defining moment that tests a company’s preparedness, values, and systems.

Expanded access and compassionate use programs give patients vital pathways to investigational therapies, but they also introduce significant operational and regulatory complexity.

The evolving landscape of expanded access programs—often referred to as compassionate use—is reshaping how life sciences organizations approach patient engagement and clinical development.

The first half of 2025 has seen a striking surge in clinical trial activity. Across therapeutic areas, but especially in oncology, companies are advancing more investigational medicines than ever before.

We recently had the privilege of hosting an interactive Q&A, "Implementing Expanded Access in Your Organization," featuring a panel of leaders and experts in the field: Paula Singer, Dr. Dennis Brown, Dr. John Langlands, and our Executive Vice President, Matthew Rosen.

Why MedaSystems’ Platform Sets a New Standard in Expanded Access Program Management

At MedaSystems, we believe in utilizing technology to expand hope. That’s why we’re paying close attention to the evolving landscape of pre-approval access, a critical pathway for patients ineligible for clinical trials to access new treatments.

Expanded Access Programs (EAPs) give patients with life-threatening conditions early access to investigational therapies, but they require strict regulatory compliance, collaboration, and data management.

Companies managing EAPs must choose between building an in-house solution or buying a specialized platform. While building in-house offers control, it comes with high costs and complexity. The smarter choice is to buy a purpose-built platform.

MedaSystems, the next-gen software platform for managing Expanded Access programs.

MedaSystems, the next-gen software platform for managing Expanded Access programs, is featured in two scientific research posters at the Society for Neuro-Oncology (SNO) Annual Meeting in Houston, TX

The MedaSystems team reflected on some learnings from the Operationalize Expanded Access Show 2024, from insights into global programs to the importance of efficiency.

Expanded Access request workflows are configured to conform to your company’s Standard Operating Procedure(s) (SOP) and, combined with the regulatory requirements of the country.

For many, how to administer Expanded Access Programs (EAPs) often leans towards outsourcing. It's a route frequently taken, perhaps because it seems like the sole feasible option.