Dedicated Peri/Post-Approval Services

Maximizing market penetration, enhancing product positioning, and increasing patient support are ever-increasing challenges for pharmaceutical and biotechnology companies. In addition, diminishing periods of exclusivity and patent protection, combined with increasing regulatory demands for long-term safety data on pharmaceutical products, have contributed to an exponential increase in the number of peri approval studies.

PAREXEL PACE™ (Peri Approval Clinical Excellence) builds upon the company’s long-standing expertise across drug development and medical marketing practices.  A dedicated global business unit, we provide customized strategic and scientific solutions to allow our clients to move from product development to commercialization in a seamless and cost-effective manner. The PACE business has built a unique operating model, supported by highly experienced subject matter experts and organised to maximize the efficiencies of our bespoke processes, tools and technologies.

Video: Neal Mantick, Sr Director Global Obsevational Research. Interviewed during the Annual DIA Meeting 2011

PAREXEL provided a wealth of capabilities for peri-approval reasearch. Working with PAREXEL provides you with access to:

• Dedicated Project Management Staff: Our project managers offer a unique depth and breadth of expertise to provide effective leadership on global or local late-phase programs.
• Global Presence, Local Market Penetration:  A global infrastructure to accommodate the need to customize the right solution based on current market dynamics for the design, launch, and management of late-phase programs.
• Focused Site Management: A worldwide network of Program Coordinating Centers which specializes in cost-effective approaches in the conduct of site management activities through a remote monitoring infrastructure in order to maximize site communications and minimize investigator burden. 
• Integrated Technologies: Validated, web-enabled, solutions for data management, along with trial management and reporting systems to automate workflow and optimize activities on the critical path.

There is no better tool to ensure study success than the insight gained though years of experience.  PAREXEL has been running late-phase studies for nearly 30 years and the PACE group was the first dedicated, global, late-phase group in the CRO industry; whatever help you need, we’ve invariably “seen it” and usually “done it.”

Working with the PACE group could not be easier.  Our project managers offer a single point of contact across all additional PAREXEL services required for a study as well as coordinating any third party vendors.  Our web reporting tools allow clients the freedom to track study progress and review live study metrics as needed and our proactive communication plans ensure that all parties are kept fully informed, motivated and up to date throughout the study.

To discuss your late phase study requirements with one of our expert advisors please contact us.