Managing patient requests for Your investigational medicines Expanded Access Programs (EAPs) allow companies to provide their investigational medicines to patients outside of the clinical trial setting, to fulfil unmet clinical needs. WEP has put [...]
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 [...]
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 [...]
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 [...]
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 [...]