Clinigen Healthcare Limited

Clinigen focuses solely on the consultancy, management and implementation of Named Patient and Early Access solutions. Clinigen supports its customers with Global Early Access/Named Patient Programs across late stage clinical development, pre- launch, launch and product withdrawal sections of the pharmaceutical life cycle, supporting patient and physician access to drugs in countries where those drugs are not approved or available.
Clinigen offers a fully outsourced solution to pharmaceutical and biotech companies looking to provide to physicians treating patients with an unmet medical need, access to their investigational / launch products prior to that product being available in that patients own country. Clinigen’s Named Patient and Early Access solutions under the leadership of a dedicated Project Manager encompass all elements from consultancy and set up of the solution, Handling Requests for Access, Regulatory Requirements, Invoicing / Credit Management, Storage, Logistics, Data Capture and Report Generation. These services are underpinned by Clinigen’s in house Regulatory, Pharmacovigilance, Medical, Logistics and Quality expertise.
At a therapeutic level the group has proven expertise in oncology, antiviral, pain management, critical care, Infectious Diseases, Respiratory, auto-immune and neuromuscular, as well as rare orphan diseases.
Our client base is diverse with organisations ranging from Global Pharma top ten companies, mid-sized Pharma/biotechnology companies through to start up, single asset organisations.