Early Access Program (EAP)allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting or drugs still under development or pending market authorization. An EAP can also be called aExpanded Access Program (EAP) or Compassionate Use Program. These programs are for patients suffering from a serious or life-threatening illness who have no viable treatment options available to them.
Globyz Group’s Early Access Programs assists manufacturers in managing compassionate use programs, including pharmacovigilance and real world data (RWD) collection.