Phase Forward Inc.

Dec. 4, 2007
eCDM Tool Improves Data Quality and Safety Review

Phase Forward has released version 2.6 of its Web Submission Data Manager (WebSDM) product. The WebSDM 2.6 software reads data from Phase Forward's InForm 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.

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