PERCEPTIVE INFORMATICS PARTNERS WITH MEDIFACTS
BOSTON, MA, February 02, 2005 — Perceptive Informatics, Inc. (Perceptive), a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), today announced the expansion of its medical diagnostics business to include electrocardiography (ECG) core lab services through a new partnership with Medifacts Ltd.(Medifacts).
Cardiac safety issues measurable by ECG have represented the most common cause of drug withdrawals from the market. As a result, regulators around the world have introduced expanded requirements for the use of ECG in clinical trials to ensure patient safety. Regulators have also worked to define requirements for the digital submission of archived ECG data, increasing the importance of appropriate ECG data collection and management.
Perceptive will utilize Medifacts’ key software tool, WebHeart™, to collect, manage, and analyze ECG data for clinical trials. The expanded services now support definitive or thorough QT Phase I trials in collaboration with PAREXEL’s Clinical Pharmacology Network, as well as Phase II/III core lab ECG services.
Perceptive’s centralized ECG capabilities complement its existing Imaging core lab services and infrastructure, which have supported hundreds of trials across a range of therapeutic areas.
Perceptive has experience with a broad array of diagnostic modalities including computed tomography (CT), magnetic resonance (MR) imaging, positron emission tomography (PET), ultrasound, nuclear medicine, and conventional radiography among others. Perceptive’s capabilities range from the application of novel diagnostic techniques in early drug development to widely validated methods for registration trials.
“Our collaboration with Medifacts brings to our clients enhanced quantitative ECG analysis for single center and multicenter cardiovascular clinical trials,” said Mark A. Goldberg, MD, President of Perceptive Informatics, Inc. “Since the data is formatted specifically for FDA submission, we can offer this innovative tool to our clients to help expedite development, with the potential to save time and cost.”
About Perceptive Informatics
Perceptive Informatics, Inc. develops and offers a portfolio of innovative technology-based products and services designed to facilitate clinical drug development and decrease time to peak sales. Perceptive offers advanced medical imaging services to rapidly and objectively assess the safety and efficacy of new drugs, biologics, and medical devices in clinical trials. The technology portfolio also includes clinical trial management systems (CTMS), Interactive Voice Response Systems (IVRS), web-based portal solutions and tracking tools, electronic diaries, and investigator database solutions. IMPACT is Perceptive’s market leading CTMS product with 15,000 users worldwide and INITIATOR is a trial management product targeted to the needs of Phase I units.
Perceptive is headquartered near Boston, MA with approximately 365 employees in offices located in North America and Europe. Perceptive Informatics is a subsidiary of PAREXEL International Corporation.
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 Medifacts International
Medifacts International is a global CRO focused on cardiovascular, renal, pulmonary, stroke, and metabolic clinical development programs for the pharmaceutical, biotech, and medical device communities. Medifacts provides a full range of clinical trial management services and is a worldwide leader in cardiac safety services such as centralized ECG, Holter monitoring, and ambulatory blood pressure monitoring. In addition, Medifacts has a unit in Görlitz, Germany, that performs Phase I pharmacokinetic studies and also acts as an investigational site for Phase III-IV studies in all clinical indications. Medifacts International maintains offices in the US, Canada, Germany, and China. For more information, visit www.medifacts.com.
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", “targets” and similar expressions are intended to identify forward-looking statements. These statements involve a number of risks and uncertainties. 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 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 Annual Report on Form 10-Q for the quarter ended September 30, 2004 as filed with the SEC on November 8, 2004, which "Risk Factors" discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent PAREXEL’s estimates as of the date of this release. PAREXEL specifically disclaims any obligation to update these forward-looking statements in the future. These 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.