Clinical Outreach
Building Consensus Behind the Need for EAP
- Open Communication with Clinical Community
- Strategic Outreach to Selected Researchers
- Assembling and Authoring Papers
- FDA Guidance as Necessary
Recruit Medical Advisory Board
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Program Development
Negotiating Relationship with Drug Developer
- Basic Program Parameters (Timing, Size, Objective)
- Program Details (Clinical Protocol, Reporting, Cost)
- Resource Allocation
Execution of EAP
- Financial Management
- Manufacturing and Distribution
- Clinical Partnership
- Patient Enrollment
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