Step-by-step EAP Management Process

Step-by-step EAP Management process The infographic outlines the processes involved in running an end-to-end Expanded Access Program (EAP). Companies need to understand all elements involved, to ensure efficient and consistent medicine supply to patients [...]

By |2024-07-23T09:50:26+01:00July 16th, 2024|

Value of Real World Data in EAP

COLLECTING REAL WORLD DATA IN EAPs We recognize the tremendous value Real World Data (RWD) can offer in the pre-approval space and work closely with our Sponsors to understand the opportunity for RWD collection in [...]

By |2024-07-16T13:37:01+01:00July 21st, 2022|

EAP Versus OLE Study

EAP VERSUS OLE Both an Open Label Extension (OLE) and an Expanded Access Program (EAP) can be used to provide continued treatment access after phase 3 clinical trials have ended.To help companies understand both programs [...]

By |2024-07-16T13:38:15+01:00January 20th, 2021|

Sponsor Considerations for EAPs

SPONSOR CONSIDERATIONS FOR EAPs If your company is developing a drug that fulfils an unmet clinical need, you may have already started receiving patient enquiries about expanded access.We have put together this downloadable resource that [...]

By |2024-07-22T10:50:38+01:00December 11th, 2020|

Expanded Access Policy Templates

EXPANDED ACCESS POLICY TEMPLATES If your company is developing a drug that fulfils an unmet clinical need, you may need an Expanded Access Policy on your website.We have provided three templates, one for each of [...]

By |2024-07-16T13:39:23+01:00March 5th, 2020|
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