Dedicated late phase services for successful commercialization

Nearly 50% of drug development companies we interviewed told us they spend more than $250 million on research and development annually; 37% of these companies spend more than $500 million. With that kind of investment, you need to leverage your product for the highest return possible in the marketplace. Combining the global resources and experience across our business, PAREXEL will manage your product’s penetration into the market by working with you to develop and evaluate your product’s effectiveness across many therapeutic areas. In addition, we have expertise in understanding medical outcomes for other similar drugs and can conduct product-to-product comparisons. Our right-pricing strategies insure that your product is well-positioned in the marketplace now, and in the future. We will help you build product awareness and demonstrated product value while also conducting long-term safety evaluations.

PAREXEL PACE understands the risks and complexities of a rapidly evolving marketplace. We are a leader in new standard risk management plans. We have deep and defined expertise in areas such as state-of-the-art methodologies, and comprehensive pharmacovigilance for the management of drug safety and risk. Our long-term relationships with and knowledge of FDA officials benefit our clients.

We understand that your company has more than one reason to conduct late phase studies. Whether it’s to meet regulatory requirements, enable label expansion to reach patients in need, develop new marketing claims, establish a long-term safety profile, or prove comparative or cost effectiveness, PAREXEL PACE has the expertise and global resources to determine, collect, and interpret the data you need to meet the needs of your stakeholders. We can manage your every need with a custom-developed strategy built to respond to and meet your individualized goals.

PARAXEL PACE understands that your company is motivated by compassion as well as solid science. We, too, believe that drug compounds should be available to those who will benefit the most. Our Expanded Access Programs include treatment IND, emergency use protocols, compassionate use guidelines, and a named patient basis program. You can trust us to honor your intentions that your drugs take care of the people who inspired you to develop them.

PAREXEL PACE doesn’t just run data reports. We partner with you in every phase of your progression from development to the marketplace. In the very beginning, we conduct health economics research that helps you achieve an optimal price, obtain reimbursement, secure a formulary place, and support product positioning. We manage all aspects of your late phase studies process and then strategize with you and provide data and analysis to maximize your long-term positioning in the marketplace. PAREXEL PACE is your strategic partner in every aspect of late phase and beyond.

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 coordinate any third party vendors. Our web reporting tools allow our 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.

PAREXEL PACE does not leave you at the shop door. We will work with you to provide ongoing health economics analyses so you can demonstrate value for the money of your product on an ongoing basis. In addition, we know that your products have ongoing post-marketing studies. Our patient safety services have been specifically designed to help bio/pharmaceutical companies meet increasing post-marketing pharmacovigilance obligations. Because we do business with you as your partner, we maintain a long-term commitment to your success and your ongoing needs.

PAREXEL has 10,000+ employees working in 52 countries. In the past three years alone, PAREXEL has conducted more than 220 international Phase IIIb/IV programs. Collectively, these studies have involved the enrollment of over 330,000 patients across approximately 29,000 sites located across the globe. In addition, we have Post-Marketing Case Processing Solutions that utilize dedicated case processing centers around the world. While currently 58% of late phase studies originate in the United States, we predict that by 2013, 62% of these studies will originate in Europe and Asia. With offices throughout Europe and Asia, PAREXEL PACE has a firm understanding of what is required to conduct studies in these environments.

We know that you have too much invested in your product—time, money, and reputation—to risk failure in the last stretch. PAREXEL PACE will not let you fail. We have significant experience in the implementation and management of all areas of late phase. As your partners, our own success depends on yours, so we are invested with you.