◎パレクセルが規制問題処理でアウトソーシングサービスを強化

AsiaNet 55811

共同JBN 0160 （2014.2.19）

【ボストン（米マサチューセッツ州）2014年2月19日PRN=共同JBN】

　＊パレクセル・インターナショナルは、クライアントの価値を高めるため一連の規制情報管理ソリューションを拡大する。

世界をリードするバイオ医薬品サービス企業、パレクセル・インターナショナル（PAREXEL International Corporation、NASDAQ：PRXL）は19日、ライフサイエンス業界向けに規制問題処理アウトソーシングサービスに的を絞った市場優先アプローチ、特に承認後の規制活動を重視して提供するよう考案された新しいサービスラインを開始すると発表した。

同社はこのPAREXEL Regulatory Outsourcing（http://www.parexel.com/solutions/consulting/

regulatory-outsourcing-services）を通じて、クライアントの独自のニーズとビジネス問題に基づくクライアント向けサービスを同社専門知識、運用上のアプローチ、テクノロジーを結合してカスタマイズする。同サービスラインは、同社事業部門パレクセル・コンサルティング（PAREXEL Consulting）内に属する。

パレクセルのマーク・A・ゴールバーグ（医博）社長兼最高執行責任者（COO）は「規制環境は常に変化しているので、製薬企業は効率とコストを念頭に置いて対応することが必要になるという新しい問題に直面している。規制上の専門知識、世界的な運用能力、情報管理技術を考慮した場合、パレクセルはこの種の新サービスを提供するユニークな立場にある。クライアントは今後、信頼できるパートナーに任せて、規制上の大部分の活動を費用対効果のある方法で外注することができるようになる」と語った。

PAREXEL Regulatory Outsourcing Servicesラインの新任責任者であるパレクセルのリック・リーゲル本社副社長は「規制問題のアウトソーシングは、市場でますます重視されるようになっており、さらに多くの企業が規制上のニーズ、特に販売製品の規制維持順守を管理する複雑なタスクを支援するアウトソーシングに依存する。今回のサービス提供はクライアントが感じている新たなプレッシャーに応えるユニークなソリューションとなり、クライアントは規制問題の運用と規制関連業務の分野で一層効率的に処理できるようになる」と語った。

PAREXEL Regulatory Outsourcing Servicesの開始は、パレクセルの規制情報管理ソリューション・ポートフォリオを拡大する。パレクセルは2012年にLIQUENT, Inc.を買収したことによって、堅ろうな情報技術プラットフォームであるLIQUENT InSight（登録商標）を追加することでその規制問題処理能力を強化することになった。

▽パレクセル・インターナショナル（PAREXEL International Corporation）について

パレクセル・インターナショナルは世界をリードするバイオ医薬品サービス企業であり、広い領域で知識ベースの委託研究、コンサルティング、医療コミュニケーション・テクノロジーソリューションを世界の製薬、バイオテクノロジー、医療機器業界に提供している。市場進出時間、ピーク・マーケット・ペネトレーションを促進するソリューションの提供にコミットしているパレクセルは、医薬品開発と規制コンサルティングから臨床薬理学、臨床試験管理（http://www.parexel.com/solutions/informatics/clinical-data-manage）、医療教育、償還までつながる開発と商品化にわたる重要な専門知識を取得している。パレクセルの子会社であるパレクセル・インフォマティクス（PAREXEL Informatics, Inc.）は、臨床開発プロセスに役立つ最先端テクノロジーソリューションを提供する。米マサチューセッツ州ボストン近郊に本社を置くパレクセルは、世界50カ国の76カ所で活動しており、従業員は1万5100人。パレクセル・インターナショナルについての詳しい情報はwww.parexel.comを参照。

PAREXEL、PAREXEL Informatics、LIQUENT、HERON はPAREXEL International Corporationもしくはその子会社の商標あるいは登録商標である

▽問い合わせ先

Diana Martin, Vice President, Corporate Communications

PAREXEL International

Tel: +1-781-434-5516

Email: Diana.Martin@PAREXEL.com

Matthew Briggs

PAN Communications

Tel: +1-617-502-4300

Email: PAREXEL@pancomm.com

ソース：PAREXEL International Corporation

PAREXEL Launches New Regulatory Outsourcing Service Line

PR55811

BOSTON, Feb. 19, 2014 /PRN=KYODO JBN / --

      -- Company broadens portfolio of regulatory information management

                         solutions to enhance client value

PAREXEL International Corporation (NASDAQ: PRXL), a leading global

biopharmaceutical services provider, today announced the launch of a new

service line designed to provide a focused, market-driven approach to

regulatory outsourcing services in the life sciences industry, with a primary

emphasis on post-approval regulatory activities.

Through PAREXEL Regulatory Outsourcing (

http://www.parexel.com/solutions/consulting/regulatory-outsourcing-services/ )

Services, the Company will customize these services for clients based upon

their unique needs and business challenges by combining expertise, operational

approaches and technology.  The service line will reside within the PAREXEL

Consulting business segment.

"With the ever-changing regulatory environment, pharmaceutical companies face

new challenges that need to be addressed with efficiency and cost in mind,"

said Mark A. Goldberg, M.D., President and Chief Operating Officer, PAREXEL.

"PAREXEL is uniquely positioned to provide this new service offering, given our

regulatory expertise, global operational capabilities and information

management technology. Clients will now be able to outsource significant

portions of their regulatory activities to a trusted partner in a

cost-effective manner."

"Regulatory outsourcing is growing increasingly important in the market as more

and more companies rely on outsourcing to help them with the complex task of

managing their regulatory needs, especially the regulatory maintenance of their

marketed products," said Rick Riegel, Corporate Vice President and new head of

the PAREXEL Regulatory Outsourcing Services line. "This service offering

provides a unique solution that addresses new pressures felt by our clients,

allowing them to become more efficient in the area of regulatory operations and

affairs."

The launch of PAREXEL Regulatory Outsourcing Services broadens PAREXEL's

portfolio of regulatory information management solutions.  In 2012, PAREXEL's

acquisition of LIQUENT, Inc. strengthened its regulatory capabilities by adding

a robust information technology platform, LIQUENT InSight(R).  

About PAREXEL International  

PAREXEL International Corporation is a leading global biopharmaceutical

services organization, providing a broad range of knowledge-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., a subsidiary of

PAREXEL, provides advanced technology solutions to facilitate the clinical

development process. Headquartered near Boston, Massachusetts, PAREXEL operates

in 76 locations in 50 countries around the world, and has 15,100 employees.  

For more information about PAREXEL International, visit www.PAREXEL.com.

PAREXEL, PAREXEL Informatics, LIQUENT, and HERON are registered trademarks 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 significantly

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 recent and

anticipated 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 recent

acquisitions of LIQUENT, Inc. and HERON, Inc., 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 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

fiscal quarter ended December 31, 2013 as filed with the SEC on January 31,

2014, 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.

Contacts:

Diana Martin, Vice President, Corporate Communications

PAREXEL International

Tel: +1-781-434-5516

Email: Diana.Martin@PAREXEL.com

Matthew Briggs

PAN Communications

Tel: +1-617-502-4300

Email: PAREXEL@pancomm.com

SOURCE:  PAREXEL International Corporation