Early Access Care helps patients and their physicians work through the process of requesting compassionate use of investigational drugs.
We are experts in Expanded Access / Compassionate Use
- Direct hands on experience leading pharmaceutical company expanded access programs
- Over 50 years' drug development and 25 years compassionate use experience
- Global expertise of local regulatory requirements for expanded access (US) and compassionate use (non-US)
- Design of Expanded Access programs and Policies
- eTool customizable for your company.
- Knowledgeable staff ready to administer your Expanded Access program
- FDA Navigator ready
- End to End management: Physician on-line request interface to approval and delivery of investigational agent to physician
- Working with IRBs and bioethical experts
- Experience with the Food and Drug Administration and global Health Authorities
Expanded Access for Groups of Patients (EAP or Cohort Protocols)