PAREXEL AND DATAFARM ASSIST IN THE PREPARATION OF FIRST eCTD SUBMISSION IN EUROPE
BOSTON, MA, December 16, 2003 — PAREXEL International Corporation (Nasdaq: PRXL) and Datafarm, Inc., a provider of electronic regulatory submission solutions, are pleased to announce their successful delivery of consulting and technical assistance in connection with the completion of an Electronic Common Technical Document (eCTD) application by Maxim Pharmaceuticals. San Diego-based Maxim recently filed its eCTD application for Ceplene™, a drug indicated for use in treating advanced malignant melanoma, with the European Agency for the Evaluation of Medicinal Products (EMEA). The EMEA has confirmed that Maxim’s application represents the first eCTD officially filed in Europe through the Centralized Procedure.
eCTD technology allows pharmaceutical and biotechnology companies to potentially reduce regulatory submission preparation time. Furthermore, in contrast to traditional paper-based formats, electronic submissions can be reviewed more efficiently by regulatory agencies, like the EMEA.
“We are delighted to have succeeded in helping Maxim achieve this milestone in electronic submissions using the novel eCTD format for drug marketing applications now being implemented throughout the industry,” noted Alberto Grignolo, PhD, President, Worldwide Regulatory Affairs, PAREXEL Consulting Group. “Our strategic collaboration with Datafarm reflects PAREXEL’s commitment to ensuring that our clients benefit from the highest quality regulatory counsel and cutting-edge submissions technology.”
“This was truly a collaborative effort,” stated Shylendra Kumar, President and CEO of Datafarm, Inc. “The engagement of Maxim was made possible through our close working relationship with PAREXEL. The team effort on the part of our organizations, coupled with automated eCTD applications developed at Datafarm, made it possible to execute this important and timely submission on behalf of the client in a world class manner.”
About PAREXEL International
PAREXEL is one of the largest biopharmaceutical 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., develops and offers a portfolio of innovative technology-based products and services that facilitate clinical drug development and are designed to decrease time to peak sales. The technology portfolio includes web-based portal solutions and tracking tools, Interactive Voice Response Systems (IVRS), Clinical Trial Management Systems (CTMS), electronic diary and investigator database solutions. Perceptive also offers advanced medical diagnostics services to assess rapidly and objectively the safety and efficacy of new drugs, biologics, and medical devices in clinical trials. 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 57 locations throughout 36 countries around the world, and has 5,105 employees.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of their respective owners and are hereby acknowledged.
About Datafarm, Inc.
Datafarm is a leading solutions provider of Electronic Document Publishing and Regulatory Submissions, Clinical Data Management, Statistical Analysis and Reporting, Document Management Systems and Custom Application Development for the Life Sciences Industry. Datafarm augments the drug development process by providing both custom and Regulatory Compliant Solutions Worldwide.
Datafarm solutions, delivered through its products and professional services, maximize the quality of publishing and efficiency of document life-cycle management. To date, Datafarm has assisted sponsor organizations with over 25 Electronic Submissions to the US and EU Regulatory Authorities
Datafarm provides solutions for the automation of the document publishing and content submission challenges facing their 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.
This release contains "forward-looking" statements regarding future results and events. 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. These statements involve a number of risks and uncertainties. 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 loss, modification, or delay of contracts; 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 the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry; 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 PAREXEL’s Form 10-Q for the quarter ended September 30, 2003 as filed with the Securities and Exchange Commission on November 12, 2003, which “Risk Factors” discussion is incorporated by reference in this press release. PAREXEL specifically disclaims any obligation to update forward-looking statements in the future. The forward-looking statements should not be relied upon as representing PAREXEL’s estimates or views as of any date subsequent to the date of this press release.