Perceptive Informatics Improves Efficiency And Clinical Data Quality With Enhanced Version Of EDC System

Perceptive Informatics, the industry's leading eClinical technology provider and a subsidiary of PAREXEL International Corporation, recently 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.

SOURCE: PAREXEL International