Protocol-Based Access Programs
How Can Sponsors Provide Treatment Access to Defined Patient Groups?
While the regulatory pathway for accessing investigational or unlicensed medicines outside of clinical trials in most countries is on a single, named patient basis, some countries either require or offer program sponsors a protocol-based option for a group, or cohort, of patients.
Whether it’s an Early Access Program, Expanded Access Program, Post-Trial Supply Program, or a Managed Access Program,
Tanner Pharma advises sponsors on the regulatory requirements and options available for each country in the program scope and manages the protocol development and submission to the competent authority.
Scenarios for Protocol-Based Access Programs
Countries in which sponsors most commonly require support for protocol-based programs include France, Germany, Italy, the United States, and the United Kingdom.
Not Sure Where to Start?
Explore our Medicine Access 101 guide for patients and HCPs.
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Regulatory Compliance
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Program Management
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Supply Chain & Logistics
Pharmacovigilance
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How We Deliver Access Solutions
Explore real-world examples of how we navigate regulatory, geographic and supply complexities to deliver compliant, global access to essential therapies.