The Clinigen Clinical Services Management team has a unique perspective when it comes to our Investigator-Initiated Studies services (IIS Services), enabling flexible processes that operate as if they were outside of a clinical study. As a part of our services, we provide Expanded Access; a programme similar to what we do with IIS, except the EAP regulatory processes are more patient-specific.
At Clinigen, we use our flexible and innovative processes to operate as if it were a normal clinical trial study, including packaging and labelling. The product is normally sent to the investigator’s site for a particular patient. The Food and Drug Administration (“FDA”) in the U.S. allows clinical studies to use investigational drugs on human subjects; whether subjects are patients or healthy volunteers.
EAP is also referred to as “compassionate use”. This program provides patients access to investigational drugs, biologics, and medical devices which are meant to diagnose, monitor, and treat them. The EAP benefits patients who have the misfortune of carrying serious and/or rare diseases for which there aren’t many therapeutic options that would be helpful in providing recovery or relief to them. Single patient expanded access provides an intimate, compassionate pathway to investigational therapies.
IIS Distribution AuthoriSations
When it comes to distribution, we have managed regulatory pathways required to facilitate the movement of materials in support of the IIS and EAP programs on an international level. Our authorised investigator-initiated studies included, for example, commercially packaged material (CPM) shipments for an EAP program to Australia and Canada.
In regards to the Australian government, the Department of Health issues a letter with the patient-specific information, which we include in each shipment as well as the Patient Access Form. For Canada, we have a Letter of Authorisation to ship materials to certain sites.
>> Read this Case Study, outlining how Clinigen’s IIS services provided smart and simple solutions to the investigators using a product from a top 10 pharmaceutical company.
