Our mission is to accelerate access of investigational drug products to patients in need
How Do We Do This?
We offer comprehensive services to manage expanded access / compassionate use program requests globally, biopharma companies can focus on drug development. From EAP / CUP development to our customizable Early Access System™ to pre-approval policy guidance, our integrated solutions streamline the process, helping you can gain market access for investigational drugs sooner.
Early Access Care offers comprehensive services covering every type of expanded access and compassionate use program on a global basis. Our Early Access Care team will design the right expanded access / compassionate use program for your company’s investigational medicinal product.
Our EAC team handles every request individually by working to review enrollment requirements, making sure that each request complies with the prespecified criteria of the sponsor. In instances when a patient is more suitable for clinical trial enrollment, we refer the patient to a clinical trial site.
Early Access Care staff work with each requesting physician and site, assisting them as they navigate the regulatory requirements necessary to obtain health authority approval.
Our broad regulatory knowledge and expertise of each country’s requirements allow us to rapidly ship investigational new drug to patients’ sites avoiding a delay due to complex customs and health authority requirements.
Early Access Care reviews every patient request on an ongoing basis for planning and coordination of future shipments of investigational medicinal products to provide up to date forecasting and planning. Our unique forecasting and inventory tracking system provide insight into required inventory levels allowing for more accurate planning.
Use our Data Sciences department to develop a plan for collection of data, from merely collecting basic information, to a full data set for rare or oncologic conditions when there is planned use of the data to support market authorization, registration, or to support Pricing and Reimbursement data collection.
Want to learn more about our Expanded Access Capabilities?