PERCEPTIVE INFORMATICS IMPROVES EFFICIENCY AND CLINICAL DATA QUALITY WITH ENHANCED VERSION OF EDC SYSTEM
BOSTON, MA, October 21, 2008 – Perceptive Informatics, the industry’s leading eClinical technology provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced the release of an enhanced version of its award-winning DataLabs® Electronic Data Capture (EDC) and Clinical Data Management System (CDMS) solution to improve the efficiency and data quality of clinical studies. The enhanced 4.3 version of the DataLabs EDC and CDMS solution enables clinical study sponsors, contract research organizations, and other service providers to harness the power of Perceptive Informatics’ extensive eClinical platform through improved, advanced integration.
The DataLabs solution is frequently combined with other Perceptive systems, including ClinPhone Interactive Voice and Web Response Systems (IVRS/IWRS) for collecting data, randomizing patients, and managing study drug inventory, as well as Perceptive’s industry-leading Clinical Trial Management Systems (CTMS), which provide planning and tracking support for all aspects of clinical trials. Additionally, the EDC system can interface with Perceptive’s industry leading Medical Imaging solution and other systems required for capture of complete clinical trial information, such as lab systems.
“EDC is the standard for capture of patient data in clinical studies, and also a critical component of a total eClinical solution,” said Steve Kent, President of Perceptive Informatics. “With a track record of providing EDC-driven solutions for more than a decade, we are focused on bringing innovation to every part of our extensive eClinical offering to help clients realize significant productivity improvements. Our enhanced EDC/CDMS solution, a key component of our integrated eClinical platform, allows for even more effective information flow across the various functions and organizations that are involved in clinical development.”
Newly enhanced features of the DataLabs solution include:
- An archive export feature for easier management and storage of selected study information
- Item-level workflow management to streamline data verification
- Read-only fields to prohibit modification of data imported from other systems, such as IVRS and lab data systems, while allowing users to perform queries and calculations based on that data
- Logo configuration for the Data Clarification Form (DCF), allowing study management to customize and brand these query forms with the study identity for communications to investigators during data validation
The DataLabs EDC/CDMS solution enables clinical study sponsors and their service providers to streamline clinical data management processes and reduce the time, cost, and risk associated with development of new products. The system incorporates the advantages and flexibility of hybrid technology, unifying paper data entry and EDC into a single clinical data management platform. The EDC/CDMS solution provides effective communication and collaboration tools for study teams through an intuitive interface, and it offers streamlined management of workflow, Case Report Form (CRF) routing and messaging, custom reporting capabilities, automated mid-study updates, and event-driven notifications. The system is among the first Clinical Data Interchange Standards Consortium (CDISC) Certified EDC systems. The DataLabs solution was previously part of the ClinPhone product portfolio.
Perceptive Informatics’ extensive, industry-leading eClinical technology offering includes:
- ClinPhone Interactive Voice and Web Response Systems (IVRS/IWRS)
- Medical Imaging
- DataLabs® Electronic Data Capture (EDC) and Clinical Data Management System (CDMS)
- Clinical Trial Management Systems (CTMS):
- IMPACT® —the industry’s leading enterprise CTMS solution
- TrialWorks® — a specialized CTMS solution designed specifically for small and mid-size companies
- Electronic Patient Reported Outcomes (ePRO)—device-based or IVR/IWR
# # #
About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry’s leading eClinical technology provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive’s expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS,) Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services. For more information about Perceptive Informatics, visit www.perceptive.com.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting 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. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has approximately 8,800 employees. For more information about PAREXEL International visit www.PAREXEL.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 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 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 or enter into new lines of business, including ClinPhone; 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 Annual Report on Form 10-K for the Fiscal Year ended June 30, 2008 as filed with the SEC on August 28, 2008, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this 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.
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 PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.