MedaSystems, the leading SaaS platform for Expanded Access, Post Trial Access, and Investigator Initiated Studies, 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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“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.

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.

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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.

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Source- businesswire