Compassionate Use & Expanded Access
Helping the scientific community with the advancement of patient healthcare.
Early Access Programs, or Compassionate Use, provide access to patients with immediately life-threatening conditions to investigational medicines, who have no alternative treatment available.
Usually, EAPs are related to the therapeutic areas of Oncology and Infectious Diseases, where regulators may permit early treatment with an investigational medicine. Once this medicine is approved for commercialization, a process to move patients from the EAP program to the commercialized drug is initiated. This process is coordinated with care by Eurotrials, as we understand that this plan needs to be careful thought in advance, especially in specific markets such as Latin America.
- Local requirements evaluation
- Risk assessment
- Protocol writing
- Global/regional regulatory services
- Data management
- Site qualification
- Initial and ongoing training
- Start-up activities
- Pharmacovigilance support
- Authority reporting
- Access to and training on a dynamic electronic data capture (EDC) system