Simplified, end-to-end solution will help biopharmaceutical clients provide compassionate access to their treatments for patients
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 operationalise. 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 MyAccessProgramsTM 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. MyAccessProgramsTM platform also provides clients with real-time progress oversight.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 18,750 employees in the first quarter. For more information about PAREXEL International visit www.PAREXEL.com.