Phase Forward Extends Standards-Based Electronic Clinical Data Management (eCDM) Submission and Safety Review Tool
WALTHAM, Mass.–(BUSINESS WIRE)–Dec. 3, 2007–Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced immediate availability of version 2.6 of its Web Submission Data Manager (WebSDM(TM)) product. The WebSDM 2.6 software reads data from Phase Forward’s InForm(TM) Integrated Trial Management (ITM) electronic data capture (EDC) product, providing data managers with the ability to better understand the overall data quality of records under review. By enabling data managers to evaluate data more thoroughly at an earlier stage, the combined products can help to detect anomalies and trends to support safety analysis.
The WebSDM product checks data for conformance with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), creating a data repository that is then available for review and reporting purposes. (The SDTM standard has been adopted by the FDA for electronic submission of clinical trial data.) The WebSDM 2.6 product can load SDTM-formatted data directly from the InForm reporting and analysis database, and allows data reviewers to drill down to InForm electronic Case Report Forms (eCRFs).
Release 2.6 of the WebSDM product provides new data integration capabilities via a Web services application programming interface (API). The API allows automated data loading to WebSDM, either from SAS V5 Transport files or from Oracle database tables, to reduce the need for manual processing.
“This new version of WebSDM helps data reviewers and clinical safety analysts who detect unusual data to then further examine a subject’s source records in our InForm product or raise queries, if needed,” said Wayne Kubick, vice president with Phase Forward’s safety division and a founding member of the CDISC board of directors. “This capability reflects Phase Forward’s commitment to support industry data standards and provide increasingly powerful and precise tools to accelerate clinical data review, analysis and evaluation. And the new Web services API, which has been designed to support the FDA/NCI JANUS project, will facilitate integration in an enterprise data architecture.”
About the WebSDM Product and Version 2.6 Features
The WebSDM product allows users to load and validate CDISC SDTM-formatted clinical trial data, to browse the data using standard views, to access and analyze patient profiles, and to prepare files for regulatory submission. The product facilitates collaboration and data sharing between stakeholders throughout the clinical development process, addressing the needs of manufacturers, clinical research organizations (CROs), affiliates and regulatory reviewers. The WebSDM product was developed under a Cooperative Research and Development Agreement between the FDA and Lincoln Technologies, Phase Forward’s safety division. The software has been in use at the FDA since 2004.
Release 2.6 of WebSDM includes the following new capabilities:
— Integration with version 4.6 of the InForm product and other database applications
— Drill-through from WebSDM 2.6 to InForm 4.6, allowing users to examine source records directly in the original context, to understand data cleaning status and to raise queries where needed
— Validated for use on 64-bit platforms and Oracle Database 10g
— Web Services API to enable automated data loading and improved integration with external data repositories such as JANUS
About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. The company offers proven solutions for electronic data capture (InForm(TM)), clinical data management (Clintrial(TM)), clinical trials signal detection (CTSD(TM)), strategic pharmacovigilance (WebVDME(TM) and Signal Management), adverse event reporting (Clintrace(TM)) and applied data standards (WebSDM(TM)). In addition, the company provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 250 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com .
