Greater emphasis on medical affairs, commercialization and lifecycle management for biopharmaceutical products

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced expanded evidence-based services for biopharmaceutical products. PAREXEL® Access focuses on clinical research and operations, market access consulting, medical communications, and pharmacovigilance to help companies identify, evaluate, generate and communicate the evidence of product value needed to successfully position a drug for market access and to support the product throughout its lifecycle.

It is estimated that the average cost to develop and gain marketing approval for a new prescription medicine, a process often lasting longer than a decade, is now $2.56 billion.1 To ensure a return on investment, the transition from clinical research and development to regulatory approval and commercial growth requires thorough data and specialized strategic expertise that integrates scientific and commercial insights.

“No longer is demonstrating safety and efficacy enough to launch a product successfully. The pressures to control the cost of healthcare coupled with the development of payer oversight organizations mean drug developers must demonstrate clear value to add a product to the treatment landscape,” said Joshua Schultz, Corporate Vice President and Worldwide Head of PAREXEL Access, PAREXEL.

PAREXEL Access combines the expertise of HERON™ Commercialization, QSI’s pharmacovigilance, PAREXEL Medical Communications, and PAREXEL Peri-/Post-approval services to offer a complete range of fully-integrated services to help clients position their products for market access and ongoing commercial success, including:

  • Evidence Identification and Evaluation: Aligning evidence generation and economic evaluation with pricing, reimbursement and market access strategy to enable our clients to make data-driven decisions to support reimbursement.
  • Evidence Generation: Providing services to clients to generate evidence of a product’s value through a range of global study types, including interventional trials, observational research, managed access programs, real-world evidence studies and drug safety programs.
  • Communication: Developing the best way to integrate complex scientific and economic data into insightful communications for key audiences, including payers, providers, patients, and policy makers.

Schultz added, “By combining our deep experience, innovative strategies, and the industry’s best minds, PAREXEL Access offers an unrivaled team of experts located throughout the world to support our clients.”

For more information about PAREXEL Access, visit www.PAREXEL.com/solutions/access.

About PAREXEL InternationalPAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract 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, medical education 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 80 locations in 51 countries around the world, and had approximately 18,620 employees in the first quarter. For more information about PAREXEL International visit www.PAREXEL.com.

PAREXEL is a registered trademark of PAREXEL International Corporation or its affiliates.

This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ materially from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from restructurings, including expense savings from the $30 – $45 million restructuring charge disclosed in the press release dated June 23, 2015; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions, and to integrate newly acquired businesses including the acquisition of Quantum Solutions India, or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of foreign currency exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.

1 Tufts CSDD Outlook 2015

PAREXEL InternationalCristi Barnett, +1-781-434-4019Cristi.Barnett@PAREXEL.comorPAN CommunicationsMatthew Briggs, +1-617-502-4300PAREXEL@pancomm.com

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