WEP Clinical creates broader treatment access solutions for patients worldwide. We do this by working with companies to set up and manage Expanded Access Programs (EAPs) and Post-Approval Named Patient Programs (PA-NPPs).
EAPs allow Sponsors to supply investigational (Pre-Approval) drugs, that are still in clinical trials, to patients who cannot enroll into active studies. NPPs allow sponsors to supply commercialized (Post-Approval) drugs to patients living in countries where they are not yet approved and available.
We offer bespoke, end-to-end solutions that can include market access solutions, data collection and safety management.
We also provide nursing services for companies running decentralized clinical trials and clinical trial sourcing for customers looking to supply their active studies and drug development programs.
Expanded Access Programs
Helping Sponsors provide investigational drugs to patients outside the clinical trial setting, to fulfil unmet clinical needs
Post-Approval Named Patient Programs
Helping Sponsors provide approved drugs to patients living in countries where they are not registered or commercially available
Market Access & Product Commercialization
Taking a Sponsor’s FDA-approved product through the approval, reimbursement, and market launch processes in Europe
Warehousing & Distribution
Ensuring products are stored, handled, and distributed compliantly, with continuous monitoring and allowing complete Sponsor oversight
Using our extensive knowledge of the regulatory process in over 100 countries to get Sponsor products expeditiously to where they are needed most
Real World Data Collection
Providing Data Collection solutions during your EAP or NPP program, which could be used to support clinical trial submissions
Delivering effective Safety Management solutions to support regulatory requirements during EAPs and NPPs
Clinical Trial Sourcing (CTS)
Sourcing pharmaceuticals, ancillary clinical supplies and active pharmaceutical ingredients for clinical trial and drug development programs
WEP Clinical possess all the necessary licenses to allow us to source, handle, store and distribute pharmaceutical drugs and controlled substances in the US, EU and ROW. All of our activities are conducted under the strict guidelines of GCP, GDP and GMP, and we have a robust set of SOPs that guide all company processes and procedures. We would be happy to provide further detail on this as requested.
Research Nursing For Decentralized Clinical Trials
WEP offers first-in-class nursing solutions for Sponsors and CROs running Decentralized Clinical Trials across the US and Europe.
We bring the clinical trial to the patient by conducting study procedures, administering treatments, monitoring patient outcomes, and managing the delivery of specimens to a designated laboratory, all from within the patient home.
Our team of research nurses are ICH-GCP certified and have extensive clinical experience caring for diverse patient groups across multiple therapy areas, including Oncology, Haematology, Rare Diseases, Neurological Diseases and Rheumatology. WEP nurses engage in ongoing research and competency training and are supported by a Clinical Trial Nurse Management team.
A pharmaceutical company developing a new treatment for a rare neurodegenerative disease had to set very strict eligibility criteria for its clinical trials. […]
A leading pharmaceutical company wanted to distribute its approved product for the treatment of a rare congenital disease into new markets where it has not yet received regulatory approval. […]
A pharmaceutical company based in North America received EMA marketing approval for its bioequivalent product for an ultra-rare disease. […]