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Clinical Trial Data Model

Phase Forward Submits XML-based Clinical Trial Data Model to Worldwide Standards Organizations

Opens Technology to Accelerate Clinical Trial Data Exchange Standards

WALTHAM, MA. June 21, 1999.

Phase Forward Incorporated has announced that it will be submitting its established eXtensible Markup Language (XML)-based data model of their InForm Web-based clinical trial data collection and management software to key industry standards organizations to jumpstart the development of a data interchange model. The Phase Forward Document Type Definition (DTD) data model written in XML will be presented to the Clinical Data Interchange Standards Committee (CDISC), a special interest group of the Drug Information Association (DIA), at its meeting on June 28, 1999. Additionally, Phase Forward also has plans to submit its DTD to the Health Level 7 (HL7) organization and the World Wide Web Consortium (W3C). CDISC, HL7, and the W3C are the primary standards organizations focused on establishing a data model and XML-based Document Type Definition (DTD) for the healthcare informatics industries.

"We are glad that Phase Forward is willing to submit its XML-based DTD to CDISC and others in the industry," said Rebecca Kush, Chairperson and Founder of CDISC. "Hopefully this will help facilitate progress in the area of data acquisition standards. We're pleased that the industry is beginning to collaborate on data standards through CDISC."

Since its inception, Phase Forward's InForm has been built on an XML platform. All trial data, meta-data, and data import/export are performed through an XML DTD. InForm is currently being used in a number of global clinical trials and is becoming the de facto industry standard for Web-based clinical trial data management.

"Phase Forward is assembling a global coalition of leaders from major contract research organizations, and leading IT and pharmaceutical companies who are helping to evaluate and refine the InForm DTD for use as an industry standard," said Paul Bleicher, Chairman and Chief Scientific Officer for Phase Forward. "As we have seen with other initiatives, an established, commercially accepted technology is the fastest and safest route to establishing a global standard."

Phase Forward has been active in the CDISC committee, and is a member of HL7 and the World Wide Web Consortium (W3C), the international standards consortium responsible for the XML standard.

XML is a markup language that is used to identify the content of textual or graphic information for efficient searching, indexing, or automated processing. XML is rapidly becoming the standard for the "tagging" of content across almost every industry that uses data exchange, and on the Internet. XML could be used by any industry or discipline that needs to exchange data to create an interchange language known as a DTD. These XML-based industry standards allow data exchange to occur without special programming or data mapping.

Currently, the disparate data models used within various pharmaceutical companies makes data interchange a cumbersome, time-consuming manual process. An XML-based DTD standard that is supported by the entire industry will allow pharmaceutical companies to exchange and aggregate data for collaborations and analysis with minimal manual intervention. This improvement can save individual companies millions of dollars in current costs.

CDISC is focused on establishing standards to improve the process of electronic acquisition and exchange of clinical trial information. It is actively pursuing: the definition of data interchange standards, without limiting the process or application implemented; ensuring that the standards are independent of platform and application; and, decreasing cycle time and cost in drug development programs.

The CDISC meeting is scheduled during the DIA conference in Baltimore, MD. Those members of the industry interested in participating in CDISC should contact Rebecca Kush at 512 750-7612 or

Information on HL7 can be found at Information on the W3C can be found at

About Phase Forward

Phase Forward Incorporated, a privately held company headquartered in Waltham, MA, offers clinical trial data collection and management software and services using Internet technologies to collect and manage essential clinical trial data in an efficient and timely way. With this Web-based software and service, sponsors of clinical trials can access clinical trial data in real-time, and begin data analysis almost immediately after the last patient has visited the clinic. By eliminating the need to transcribe and process traditional paper data forms, clinical trial sponsors can accelerate the delivery of new and beneficial drugs and medical devices to market, and maximize their revenue potential. For more information, visit Phase Forward at


Phase Forward Incorporated
Karen Wills
Tel: 888/703-1122 x 3350

Prepared by Robin Cover for the The SGML/XML Web Page archive.

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