Parexel International, a global biopharmaceutical services provider, has launched an expanded Managed Access Programs service. Parexel now offers end-to-end expertise for the design, development and delivery of managed access programs to help biopharmaceutical companies provide access to investigational medical products for patients in need.
Managed Access Programs provide use of an investigational medical product by a patient when enrollment in a clinical trial is not possible. Often called “Compassionate Use” or “Expanded Access,” these programs allow patients to obtain direct and rapid access to a therapy while regulatory or reimbursement processes are still ongoing. A treating physician or patient may request such access in the absence of comparable or satisfactory alternative therapy or when the investigational product presents less risk than the disease or condition for the patient.
“Managed Access Programs can be complex to operationalize. They require expertise and experience in managing these types of programs as well as a global network to deliver these solutions with key agencies, regulators, local decision makers, and the medical community,” said Peggy Schrammel, vice president, Managed Access Programs, Parexel. “Parexel’s unique configuration of simplified, end-to-end services for Managed Access Programs includes seasoned operational teams, global regulatory expertise, proprietary technology, and global clinical logistics.”
In addition to designing all aspects of the program, Parexel clinical logistics experts manage the supply of the medicinal product, ensuring on-time delivery and ongoing availability of product for each enrolled patient on a worldwide basis. Leading global safety experts oversee all aspects of pharmacovigilance and reporting requirements of safety events, while market access experts help clients determine the utility of collected data for commercial and medical stakeholders as indications of real world value.
Parexel’s expanded Managed Access Programs service is available around the world as part of the MyAccessPrograms platform, a proprietary technology of Parexel. The platform can support multiple Managed Access Programs for a client, including patient identification, physician enrollment, stakeholder communications management, and drug supply management. MyAccessPrograms platform also provides clients with real-time progress oversight.