PAREXEL complements our customers’ capabilities by utilizing many facets of our integrated expertise to help our customers optimize development and increase global market access across all phases of clinical development and a broad range of therapeutic areas. We continuously expand our expertise to support our customer needs, particularly in the management of increasingly complex, global programs.
As many regulatory, medical, and scientific issues change the clinical development environment, PAREXEL is committed to easing these challenges for customers. The creation of The PAREXEL Expert Office signals a new level of partnership between PAREXEL and our customers. We enable customers to make better, more informed decisions earlier, helping to decrease risk of late phase failure by applying specific early phase expertise in Phase I and Proof of Concept studies. We excel by applying specific expertise in the design and execution of peri- and post-approval studies, reimbursement and market access strategies, and proactive strategic compliance approaches. And, through innovative and adaptive trial designs, we assist companies in collecting data sooner, with fewer studies.
The PAREXEL Expert Office fosters a strong relationship among medical practice, regulatory and clinical operations considerations across a broad range of therapeutic areas to provide insightful strategic guidance for our customers’ compounds in development.
Through the PAREXEL Expert Office, customers collaborate with a team of global experts who develop customized strategies and oversee optimal execution of trials. These experts, many of whom are former regulators, pharmaceutical company executives, or leaders of medical institutes, draw on their in-depth regulatory, business, and scientific expertise. They address a spectrum of issues that may impact critical areas for customers such as safety, pricing, reimbursement, compliance, and approval.
The PAREXEL Expert Office offers capabilities such as development plans for successful marketing authorizations and launch; product class assessments and deep medical insight for specific indications and multi-therapeutic areas; protocol review to identify gaps that may delay development; and insight into regulatory guidelines and management of successful regulatory interactions.
PAREXEL is your reliable source for regulatory, medical and scientific expertise - any where in the world.
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