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MedaSystems Demonstrates AI-Powered Breakthrough in Real-World Data Analysis

New research demonstrates how MedaSystems’ AI technology transforms complex Expanded Access data into actionable, traceable insights for pharmaceutical companies.

MENLO PARK, Calif.--(BUSINESS WIRE)--MedaSystems, a leading provider of secure, validated software for Expanded Access Programs (EAPs) and Post-Trial Access (PTA), today announced new research demonstrating how its AI technology can unlock valuable insights from real-world patient data.

“Expanded Access Programs generate a wealth of valuable real-world data, but historically much of that data has been difficult to analyze systematically. We’ve built MedaSystems to simplify the management of these complex programs.”

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The research demonstrates how MedaSystems is extending the value of its platform beyond managing the complex workflows and compliance requirements of Expanded Access Programs to helping pharmaceutical companies analyze the treatment data generated by those programs.

The study entitled, “AI-Powered Natural Language Interface for Real-World Data Analysis in Neuro-Oncology Expanded Access Programs,” was authored by M. Rosen, J. Thibeault, S. Mukherjee, C. Kamiya, J. Langlands, and D. Brown and is being presented at the 31st Society for Neuro-Oncology Annual Meeting on November 13, 2026, in Philadelphia, PA. You can review it here. The authors used MedaSystems’ MCP Server, built on the open Model Context Protocol standard to enable AI-powered analysis of de-identified, real-world treatment data from a neuro-oncology Expanded Access Program.

Turning Expanded Access Data into Actionable Insights

Expanded Access Programs generate valuable real-world treatment data, including patient characteristics, treatment histories, safety observations and outcomes. Yet much of this information remains difficult to analyze because it is distributed across treatment records and unstructured notes.

MedaSystems’ technology enables researchers to query this information using natural language to identify treatment patterns and generate structured analyses with direct traceability to original patient records.

The study examined an Expanded Access Program for the investigational therapy VAL-083 (dianhydrogalactitol), an investigational, central nervous system-penetrating, DNA-targeting agent which bypasses resistance mechanisms in high grade gliomas, particularly in MGMT-unmethylated tumors. The study encompasses 81 patient inquiries across 16 institutions, including 39 treated patients.

Key findings included:

  • Consistent, reproducible results: Four independent AI analyses, using two AI models across two environments, consistently reproduced core patient cohort figures.
  • Identification of treatment patterns: AI-assisted analysis identified differences in treatment duration across diagnostic groups and biomarker categories, generating hypotheses for further investigation.
  • Transparency and traceability: Findings could be checked against original treatment records, supporting verification and distinguishing documented observations from clinical interpretation.

The research also demonstrated the potential to streamline recurring program reports, reducing manual data compilation while improving consistency and accessibility.

“Expanded Access Programs generate a wealth of valuable real-world data, but historically much of that data has been difficult to analyze systematically,” said Matt Rosen, Co-Founder and CEO of MedaSystems. “We’ve built MedaSystems to simplify the management of these complex programs. This research demonstrates how our AI technology can extend that value by helping pharmaceutical companies uncover meaningful insights from the real-world data they already collect, while maintaining the transparency and traceability essential in life sciences.”

Expanding the Value of the MedaSystems Platform

The research builds on MedaSystems’ continued investment in AI capabilities designed specifically for pharmaceutical operations. MedaSystems recently introduced its MCP Server in beta, enabling compatible AI assistants to analyze Expanded Access Program data through natural language queries while respecting existing access permissions and providing direct references to source records.

Together with the company’s existing AI-powered patient health information redaction capabilities, this technology demonstrates how AI can support both the efficient management of Expanded Access Programs and more effective use of the real-world data they generate. For pharmaceutical companies, these capabilities offer opportunities to improve program monitoring, supply forecasting, safety review, and the generation of real-world evidence.

About MedaSystems

MedaSystems is a leading provider of secure, validated SaaS software that helps life sciences organizations manage Expanded Access Programs (EAPs), Post-Trial Access (PTA) and Investigator-Initiated Studies (IIS). Trusted by leading global pharmaceutical companies, the MedaSystems platform combines configurable workflows, centralized data management, automation, and comprehensive governance and compliance capabilities to simplify complex medical programs. With integrated AI capabilities, MedaSystems is helping pharmaceutical companies improve operational efficiency and unlock greater value from the clinical data generated by these programs.

For more information, visit www.medasystems.com.

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Media Contact
Aimee Caton
VP of Marketing
MedaSystems
aimee@medasystems.com

MedaSystems


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Contacts

Media Contact
Aimee Caton
VP of Marketing
MedaSystems
aimee@medasystems.com

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