MedaSystems Reports Breakthrough Year of Global Growth, Clinical Trust, and Platform Expansion
MedaSystems, the leading SaaS platform for Expanded Access, Post Trial Access, and Investigator Initiated Studies, today announced a milestone year defined by accelerated customer growth, strong clinical adoption, and significant advances in regulatory and AI readiness. The company continued to expand its role as a trusted partner to life sciences organizations and clinicians seeking treatment pathways for patients with urgent medical needs.
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MedaSystems, the leading SaaS platform for Expanded Access, Post Trial Access, and Investigator Initiated Studies, today announced a milestone year defined by accelerated customer growth, strong clinical adoption, and significant advances in regulatory and AI readiness.
MedaSystems continues to support a diverse and growing customer community. A sampling of current customers includes:
- A top twenty global biopharmaceutical company with a market-leading antiviral and oncology portfolio
- A major European pharmaceutical organization with a strong rare disease footprint
- A global specialty therapeutics company focused on respiratory and rare conditions
- An international biopharma partnership dedicated to advancing therapies for infectious diseases
- An emerging biotech oncology manufacturer developing targeted therapeutics
Global Reach Across High-Impact Therapies
MedaSystems supported a broad range of activities across various therapeutic areas during the year, including oncology, metabolic and genetic diseases, dermatology, infectious diseases, and neurology. The platform facilitated pre-approval access programs across many regions worldwide and supported the delivery of advanced therapies for both rare and high-need conditions. This global footprint highlights the increasing complexity of pre-approval access and the industry-wide shift toward modern, compliant digital infrastructure.
Widespread Clinical Trust Across Leading Institutions
Since its founding, clinicians at nearly three hundred institutions have used MedaSystems to coordinate pre-approval access requests. These institutions include many of the world’s leading academic medical centers, university hospitals, national referral centers, pediatric specialty hospitals, and top-ranked cancer programs. More than one-third of these organizations are high-prestige clinical or research institutions, underscoring the strong trust they have earned from the medical community.
Institutional adoption spans North America, Europe, Asia Pacific, Latin America, and the Middle East, making MedaSystems one of the most geographically diverse Expanded Access networks in the industry.
Advancing AI for Access Programs
MedaSystems continued to build on its early leadership in applied AI for regulated workflows. The company’s PHI Redaction Agent has processed thousands of document interactions across sponsor programs.
The agent performs deterministic, auditable actions within strict guardrails and routes each suggested change through a human approval step before finalization. These innovations reflect the company’s long-term vision to bring safe, transparent automation to the workflows that matter most in Expanded Access and related programs.
Executive Commentary
“2025 has been a milestone year for MedaSystems as we continue to redefine how life sciences organizations manage Expanded Access worldwide,” said Brian Irwin, CEO, MedaSystems. “The rapid growth of our customer base and the trust placed in us by global pharmaceutical leaders reflect the industry’s need for modern, compliant, and scalable solutions. We’re proud to support sponsors and healthcare professionals in bringing critical therapies to patients faster, and we’re excited to build on this momentum in the year ahead.”
Regulatory Momentum and the Evolving Role of Pre-Approval Access
In November, the FDA introduced the Plausible Mechanism Pathway, a major regulatory development that expands the role of pre-approval access programs. Under this approach, data generated through certain single-patient Expanded Access cases may contribute to the evidence supporting approval of individualized or genetically targeted therapies.
The introduction of this pathway is expected to increase demand for structured, high-fidelity real-world evidence produced within access programs. MedaSystems’ global case management, audit-ready documentation, and longitudinal follow-up capabilities will enable sponsors navigating this emerging regulatory era.
Looking Ahead
MedaSystems enters 2026 with strong momentum, supported by expanding partnerships, continued platform adoption, and rising recognition from clinical and regulatory communities. The company will continue investing in workflow intelligence, regulatory innovation, and modern infrastructure that supports timely patient access to investigational therapies worldwide.
About MedaSystems
MedaSystems is the leading developer of secure, GxP-compliant software for managing requests for experimental therapies—including Expanded Access, Post-Trial Access, and Investigator-Initiated Studies. By connecting physicians and pharmaceutical companies in a centralized, audit-ready environment, MedaSystems reduces administrative burden, improves data quality, and helps patients worldwide gain timely access to investigational treatments.
Media Contact
Aimee Caton
Vice President, Marketing
MedaSystems
+1 650 515 1295
aimee@medasystems.com
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