Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.
Independent Review Committees (IRCs) provide a valuable resource to biopharmaceutical companies. These committees provide a sponsor with valuable guidance and decision-making on requests for Expanded Access and Compassionate Use. IRCs can be used for one or more of a sponsor company's investigational drugs. When evaluating individual requests for compassionate use the committee ensures that:
- All patients are treated fairly and equally
- Fulfillment of the compassionate use request does not compromise the clinical program
- Patients are not placed in unforseen harm
IRCs are cromprised of experts from the field of medicine, bioethics and a patient representative. If a sponsor selects to use an IRC, each request for compassionate use is reviewed by the IRC and a recommendation is made to the sponsor company.
Early Access Care can develop and implement the review committee that is most suitable for your investigational drug.