News & Events

Phoenix Data Systems Extends EDC Platform and Electronic Submission Capabilities

KING OF PRUSSIA, PA—February 25, 2008 - Phoenix Data Systems, Inc., a top electronic data capture (EDC) and clinical data management solutions provider, today announced immediate availability of version 4.1 of PDS Express™ electronic data capture software for global clinical trials with enhanced submissions-ready data capabilities.

The improvements in version 4.1 add to Phoenix Data System’s industry-leading capabilities, including:

• Personalization enhancements to provide multiple types of study definable marking abilities. Users can customize and retain their preferences such as the sorting or columns for viewing listings and are visible and/or controlled by user role definitions.
• Extending data visibility during a study, PDS Express 4.1 provides the ability to filter by dates on both the data and query listings, and to more easily combine data listings from the different forms for export including all of the forms at once.
• Enhanced support for multiple studies includes the ability access all permissible studies or switch between studies with a single log-in. User permissions provide the ability to filter the listed studies.
• PDS Express’ renowned ease of use is advanced with new data entry features such as a single click to clear all the entries on a form, auto-complete combo boxes, customizable date and time formatting, and more.
• PDS Express 4.1 also implements a new extensibility model that provides PDS with an unrivaled ability to customize the system for sponsors or trials, in faster time frames.

The company also announced that clinical trials conducted using Version 4.1 will be supported with the PDS IPP (Individual Patient Profile) Generator. This capability produces Individual Patient Profiles in PDF format fully compliant with FDA electronic submission guidelines for all data contained in the PDS Express database. This typically includes all eCRF and IVR information, as well as lab information and images linked to eCRF forms. These PDF documents are automatically hyperlinked and bookmarked for compliance with regulatory guidelines and are ready for eCTD submission or may be printed if desired. The PDS IPP Generator is especially useful for later phase pivotal trials, in support of electronic submissions, required for New Drug Applications (NDA).

Automating the patient profile process reduces errors and enables faster submission at a more predictable price. The PDS IPP Generator will be included as a standard component of all PDS studies at no extra charge, a significant savings for sponsors when submitting their regulatory filings.