Compassionate Use & Expanded Access
Helping the scientific community with the advancement of patient healthcare.
Early Access Programs, or Compassionate Use, provides access to patients with immediately life-threatening conditions to investigational medicines, who have no alternative treatment available.
The most common designs for EAPs are Clinical Trial Design protocol-driven and completed under a treatment or pending application for marketing authorization, and Named Patient, with an approval given case by case, for single patients.
Usually, EAP are related to the therapeutics 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
- Rapid and targeted start-up activities
- Initial and ongoing training
- Customized patient and site/clinical practice support tools
- Pharmacovigilance support
- Authority reporting
- Access to and training on a dynamic electronic data capture (EDC) system