Expanded Access & Expermental Drugs for Patients
Expanded access, or compassionate use, contributes to breakthroughs in pharmaceutical development—and our patients are at the heart of each one. At Early Access Care, we work with your physician or care team to facilitate the expanded access request process, keeping things moving efficiently so you can get the treatment you need, faster.
At Early Access Care we are committed to supporting early access to medicines for individuals requiring medicines in those cases where the patient and their treating physician decide on a treatment plan, after carefully considering treatment options. Patients need to be able to make decisions about their health care, including using experimental therapies when appropriate. This requires a candid conversation about available therapies and potential treatment options.
How Does It Work?
Only your physician can make a request for an investigational medicinal product on your behalf. They start by identifying the drug manufacturer or its representative such as Early Access Care, to identify whether the experimental drug is available for early access. Not all experimental medicines are available while an experimental drug is undergoing rigorous testing for safety and effectiveness in ‘clinical trials’.
What We Do
If an experimental medicine is available for early access, and Early Access Care is the service provider managing the requests on behalf of the pharmaceutical company, Early Access Care will help your physician go through the proper steps to obtain required approvals. Once approved, Early Access Care will make sure the experimental medicine is delivered to the physician or the hospital. If the medicine is needed once or for a longer time, Early Access Care will always ensure your medicine is delivered to your physician when it is needed.
In the United States the request is made through a process called “Expanded Access”, sometimes referred to as Compassionate Use.
In Europe and the United Kingdom, each country has its own regulations, and the process has a different term in each country.
Want to learn more about our Expanded Access Capabilities?