Expanded Access Programs
CSI is the Leading Patient Centric Biopharmaceutical Service Providing Company
We work with Biopharmaceutical companies to make investigational promising products available to patients.
We have initiated many Expanded Access Programs (EAPs) and we are therefore familiar with the regulations and requirements. True to our core mission to improve patient outcomes, these programs generate much needed safety data.
EAPs are also called Named Patient Supply (NPS), Investigational New Product (IND) protocol, Compassionate Use Program (CUP), or Managed Access Programs (MAP).
An EAP provides access to investigational products to treat patients with serious or immediately life-threatening conditions who have no satisfactory alternative treatment options. These products have not yet been approved by regulatory authorities.
Benefits to Patients and Biopharmaceutical Companies:
- Provide patients early access to potentially life-improving or saving treatments prior to regulatory approval
- Serve as a way to provide patients continued access to treatment following a pivotal trial
- Expand the availability of the investigational product beyond the patient population typically seen in a Phase II or III study
- Provide pharmaceutical companies a way to collect additional safety data and expand the safety profile of the therapy
- Provide pharmaceutical companies a way to gain pre-market experience and establish a base of patients that may continue to utilise the investigational product upon approval