Pharmaceutical Expanded Access

Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.

Independent Review Committees

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.