Our Mission

Early Access Care's mission is to accelerate access to investigational drug products to patients in need

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.

How We Make A Difference

Solutions for Patients

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

Solutions for Physicians

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

Pharmaceutical Solutions

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

Value for Biopharmaceutical Companies

Our services deliver 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

The Intangibles

  • Patient and physician satisfaction with a request being managed efficiently
  • Your organization’s reputation of managing each request as a priority and professionally

Contact Early Access Care

We are experts in Expanded Access.
We are here to help you.

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

Email or Call Us at (203) 441-7938
(Toll Free: (888) 315-5797)

40 Mungertown Road,
Madison, CT 06443