We Provide Solutions
Early Access Care serves as a conduit between patients, physicians, and biopharmaceutical companies providing the insight, expertise and resources necessary to respond to requests for expanded access/compassionate use.
Early Access Care guides biopharmaceutical companies in understanding the new 21st Century Cures legislation and FDA Final Rule and to develop and implement the right solution. Early Access Care is FDA Navigator-ready.
Early Access Care provides functional support across the entire request process: assisting the physician and biopharmaceutical company in managing the request and approval, tracking the request and all required elements, providing education on proper handling of the investigational drug, and verifying that the investigational drug is received by the physician.
Value for Pharmaceutical Companies We provide value to your organization
Value in Time
- Early Access Care and our systems allow immediate compliance with 21st Century Cures legislation and FDA Final Rule
- Our system and people are ready to provide services, mitigating delays due to Sponsor system development and implementation
- Early Access Care is FDA Navigator-ready
- Our experience in developing Expanded Access Protocols (EAPs) will accelerate your implementation
Value in Cost
- Your internal resources are focused on drug development and not on managing compassionate use requests – this advances your filing and approval
- Mitigates sponsor platform development costs
- Patient and physician satisfaction with a request being managed efficiently
- Your organization's reputation of managing each request as a priority and professionally