BOSTON, July 9, 2015 -- PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced expanded services and capabilities in model-based drug development (MBDD) through their Quantitative Clinical Development (QCD) group. The PAREXEL QCD team also offers leadership in all strategic and quantitative aspects of clinical pharmacology for biopharmaceutical companies to help expedite drug development, minimize risk, and support regulatory approval processes.
Leveraging mathematical models for a quantitative analysis of the relationship between drugs, disease and patients, modeling and simulation can predict a drug's benefits and adverse effects in a patient population prior to conducting a clinical trial. MBDD can improve the efficiency of clinical development by providing quantitative justification for trial design, dose selection, and decisions during trial execution. In addition, quantitative clinical pharmacology throughout the lifecycle of a drug candidate supports high quality regulatory packages to help secure regulatory approval.
"The biopharmaceutical landscape continues to show dramatic change, putting companies under increasing pressure to deliver on their pipeline, to identify more effective means of picking the 'winners' and efficiently developing these medicines under financial constraints. In addition, regulatory authorities around the world have increasingly accepted model-based techniques as a standard component of new drug applications," said Frank Hoke, PhD, Vice President of QCD, PAREXEL. "Our goal is to reduce risk along the drug development continuum – for drug developers and for patients – while helping companies make sound investment decisions and accelerating their drug's journey to market."
PAREXEL's Quantitative Clinical Development, one of the largest groups in the industry providing modeling and simulation, is led by Dr. Hoke and supported by a dedicated team of more than 30 scientists with an aggregate of 400-plus years of combined clinical development experience. Dr. Hoke and a number of colleagues joined PAREXEL from GlaxoSmithKline's Clinical Pharmacology Modeling and Simulation department.
For more information about PAREXEL's QCD modeling and simulation and quantitative clinical pharmacology services, visitPAREXEL.com/solutions/clinical-research/quantitative-clinical-development.
About PAREXEL International
PAREXEL 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, Inc. provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 80 locations in 51 countries around the world, and had approximately 17,440 employees in the third quarter. For more information about PAREXEL International visitwww.PAREXEL.com.
PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners.
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; 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 acquisitions of ClinIntel Limited and 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 as filed with the Securities and Exchange Commission on May 1, 2015, 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.
Diana Martin, PAREXEL International
Tel: +1 781-434-5516
Email: [email protected]
Cristi Barnett, PAREXEL International
Tel.: +1 781-434-4019
Email: [email protected]
Matthew Briggs, PAN Communications
Tel: +1 617-502-4300
Email: [email protected]
SOURCE PAREXEL International Corporation