Our Mission

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.

Early Access Care helps patients and their physicians work through the process of requesting compassionate use of investigational drugs.

Early Access Care makes it simple for physicians to request investigational drugs through a locally approved mechanism.

Early Access Care is the solution to pharmaceutical company compliance with the new legislation as it pertains to Expanded Access.

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

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

To hear more about any of the Early Access Care services or to discuss how we can support your organization, contact us.

40 Mungertown Road,
Madison, CT 06443