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|

Collecting RWD in EAPs

WHY COLLECT REAL WORLD DATA IN AN EXPANDED ACCESS PROGRAM? Expanded Access Programs (EAPs) provide sponsors the opportunity to collect meaningful Real World Data (RWD), i.e. data on health care that is [...]

By |2024-03-01T09:20:07+00:00April 28th, 2022|

PA-NPP Product Uptake By Country

Product Uptake By Country PA-NPPs adhere to strict legislation regarding the supply of unlicensed medicines on an unsolicited request basis. As such, there are many factors that determine the level of uptake in a PA-NPP, [...]

By |2024-07-16T13:37:34+01:00November 25th, 2021|

Case Studies

Case Studies WEP Clinical is committed to supporting companies in the pharmaceutical industry to help make much-needed medicines available to patients, physicians, hospitals and R&D centers. EAP PA-NPP Market Access Nursing Expanded Access Check out [...]

By |2025-07-11T16:03:07+01:00May 5th, 2021|

Resources

Resources All Resources|Real World Data Resources|Market Access Resources|Expanded Access Resources|Open Label Extensions Resources|Post-Approval Patient Programs Resources|Harnessing Real-World Data for Market Access Success24th July 2024/DOWNLOAD PDFStep-by-step EAP Management Process16th July 2024/DOWNLOAD PDFNavigating Asset Transitions that include [...]

By |2024-09-19T13:32:19+01:00January 28th, 2021|

Post-Approval Named Patient Programs

Post-Approval Named Patient Programs A Post-Approval Named Patient Program (PA-NPP) allow Sponsors to make their approved medicines available in countries where they are not yet approved or commercially available. Sponsors can make their product available [...]

By |2025-07-09T21:52:01+01:00January 22nd, 2021|

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|

Market Access

Market Access Strategic Consulting We specialize in access strategies for rare, oncology, gene and cell therapies across Europe, supporting clients navigating the transition from clinical development  to commercialization. Integrated Market Access Strategy A successful Market [...]

By |2025-07-09T11:07:25+01:00October 29th, 2020|

Blogs

WEP Blog All PostsNursingExpanded Access ProgramsReal World DataEarly Access Programs – What to Consider as a Patient10th October 2023/Read MoreBenefits of Homecare Nursing in Clinical Trials19th September 2023/Read MoreWhere Can an EAP Fit Into the [...]

By |2024-11-14T09:39:49+00:00May 4th, 2020|