PAREXEL AND DATAFARM ESTABLISH COLLABORATIVE AGREEMENT TO CO-MARKET ELECTRONIC REGULATORY SUBMISSIONS SERVICES
BOSTON, MA, October 7, 2002 — PAREXEL International Corporation, (Nasdaq: PRXL) one of the world’s largest biopharmaceutical outsourcing companies, today announced a collaborative agreement with Datafarm Inc., a Marlborough, MA-based company, to co-market services related to electronic regulatory submissions. e-Submissions are increasingly a key component of the regulatory approval process for pharmaceutical and biotechnology companies. In September 2002, the International Conference on Harmonization (ICH) gave final approval to the electronic Common Technical Document (e-CTD) Guideline, paving the way for the submission of standard-format electronic marketing applications to regulatory authorities in the United States, European Union and Japan.
Under the terms of the agreement, PAREXEL will offer Datafarm’s integrated e-Submission solutions in combination with its extensive portfolio of worldwide regulatory services that include strategic regulatory consulting, technical writing and dossier preparation. PAREXEL believes that this collaboration will benefit clients by combining PAREXEL’s expert regulatory consulting services with Datafarm’s electronic publishing capabilities to produce reviewer-friendly, easily navigable marketing applications in electronic format for submission to global regulatory authorities. PAREXEL and Datafarm have already collaborated on several projects for clients, resulting in electronic submissions to the Food and Drug Administration.
“PAREXEL takes pride in its commitment to providing quality regulatory solutions to clients,” noted Alberto Grignolo, Ph.D., President, Worldwide Regulatory Affairs. “Through the use of Datafarm’s broad e-Submissions technology platform, we are able to provide clients with sophisticated and cost-effective tools to complement our regulatory consulting services and to produce reviewer-friendly electronic regulatory submissions.”
“We are pleased to form an alliance with PAREXEL,” stated Shylendra Kumar, President and CEO of Datafarm. “We believe that this alliance, by leveraging PAREXEL’s broad range of biopharmaceutical services, will provide clients with a core competency of high-quality, flexible and cost-effective services to meet the regulatory requirements associated with electronic submissions," stated Kumar.
Datafarm, Inc., a Marlborough, MA-based company, is a leading provider of electronic document publishing and regulatory submission solutions for the Life Sciences Industry. Datafarm augments the drug development process by providing both custom and regulatory compliant solutions in the areas of Electronic Regulatory Submissions. Datafarm provides products and services including e-Submissions; Clinical Data Analysis and Reporting; Custom Application Development; Custom Acrobat plug-ins; SAS programming; Electronic Document Management System (EDMS); and Custom web-based applications.
Datafarm provides solutions for the automation of the document publishing and content submission challenges facing our Life Sciences customers seeking regulatory approval of drugs, medical devices, and other therapeutic and diagnostic products. Datafarm’s solutions have assisted its clients in producing high-quality, agency-compliant e-Submission-ready documents. The impact of these timely solutions has been translated into improved internal workflow efficiencies, lower production costs and reduced time to submission, saving its clients both money and precious time to regulatory approval.
About PAREXEL International
PAREXEL is one of the largest pharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that expedite time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. Its information technology subsidiary, Perceptive Informatics, Inc., provides a variety of technology products and services, including web-based portal solutions and voice and data systems, which are designed to accelerate and enhance the clinical development and launch processes. PAREXEL’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 56 locations throughout 37 countries around the world, and has approximately 4,930 employees.
This release contains "forward-looking" statements regarding future results and events, including statements regarding expected financial results, future growth and customer demand that involve a number of risks and uncertainties. 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” and similar expressions are intended to identify forward-looking statements. PAREXEL'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 restructurings; the cancellation, revision, or delay of contracts, including those contracts in backlog; PAREXEL's dependence on certain industries and clients; PAREXEL's ability to win new business, manage growth, and attract and retain employees; PAREXEL's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of certain industries and clients; competition and consolidation within the pharmaceutical 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 and political risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of PAREXEL's Form 10-K for the period ended June 30, 2002, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. PAREXEL disclaims any duty to update any of the forward-looking statements contained in this press release.