PAREXEL has expanded its Managed Access Program service for the design, development, and delivery of managed access programs, which help biopharma companies provide investigational products to 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 and allows patients to obtain direct access to a therapy while regulatory or reimbursement processes are still ongoing. 
 
“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 the program, PAREXEL manages clinical logistics for the supply of the drug product,  helping to ensure on-time delivery and ongoing availability for each patient on a worldwide basis. Also, global safety experts oversee 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.
 
The service is available as part of the MyAccessPrograms platform technology, which can support multiple Managed Access Programs, including patient identification, physician enrollment, stakeholder communications management, and drug supply management.  It also provides clients with real-time progress oversight.