MedaSystems for Post-Trial Access
Continue treating patients after clinical trials end
Simplify Post-Trial Access When Open-Label Extension Studies Aren’t Feasible
Post-Trial Access (PTA) programs provide a critical pathway for continuing patient care after clinical trials conclude, particularly when Open-Label Extension (OLE) studies are not a viable option due to cost, operational complexity, or timelines.
MedaSystems enables seamless PTA program management, ensuring patients maintain access to life-saving therapies while companies meet their ethical and regulatory commitments.
How our customers use MedaSystems for Post-Trial Access
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Site collaboration
As the clinical trial ends, sponsors invite site physicians and staff into MedaSystems to complete forms and upload necessary documents, streamlining transitions into PTA programs.
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Eligibility review
With MedaSystems running in the cloud, multiple colleagues can collaborate simultaneously, enabling faster, more informed decisions on patient eligibility.
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Drug shipment
Biopharma teams—and optionally healthcare providers—can initiate and track drug shipments directly within MedaSystems, ensuring timely delivery of treatments.
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Treatment history
Digital forms capture structured data for reporting, regulatory compliance, internal audits, and shipping processes, providing a transparent and consistent record.
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Data analysis
Analyze treatment and program data to uncover actionable insights that support regulatory submissions, strategic planning, and long-term business goals.
Patients have a seamless transition from clinical trials to Post-Trial Access
How MedaSystems Supports Post-Trial Access
Unified Platform: Manage PTA programs alongside Expanded Access and Compassionate Use within a single system for streamlined operations.
Accelerated Setup: Quickly operationalize PTA programs with pre-configured workflows and templates.
Compliance Confidence: Ensure regulatory adherence with built-in tools and detailed audit trails.
Real-World Data Collection: Leverage PTA program data to strengthen treatment assessments and regulatory filings.
Cost-Effective Operations: Avoid the high costs and complexity of OLE studies with a scalable PTA approach.
Why Choose Post-Trial Access?
Continuity of Care Without OLE Studies
PTA programs offer a practical, cost-effective alternative to OLE studies, ensuring trial participants can continue receiving beneficial treatments without gaps in care.Integrated Management
Since PTA programs are often managed by the same teams handling Expanded Access and Compassionate Use, MedaSystems provides a unified platform to run all access programs efficiently.Ethical and Strategic Alignment
PTA programs allow companies to fulfill ethical obligations to trial participants while gaining opportunities to collect real-world data, build stronger relationships with healthcare providers, and inform regulatory and commercial strategies.
