Philadelphia, PA—August 18, 2009

GlobalSubmit Inc., a developer of software designed for the review and validation of electronic Common Technical Document (eCTD) global submissions, has launched a project focused on developing a prototype that loads HL7 messages into a Janus Version 2 database and exports those messages in a Study Data Tabulation Model (SDTM) file format.

While the company is close to completing the development of that prototype, it has also extended the model so that it will load and export both SDTM and HL7 files. Recently, GlobalSubmit and the FDA began the actual testing of these solutions by reviewing HL7 Study Design, Study Participation, and Subject Data.

In late July, GlobalSubmit met with the National Center for Toxicological Research (NCTR) at its offices in Jefferson, Arkansas. While there, GlobalSubmit installed the prototype Janus Version 2 database. GlobalSubmit also reviewed the Study Design prototype, which, when in production, will expedite the protocol review process. That prototype runs seamlessly “on top of” the Janus prototype database.  

During the pilot period, the FDA will receive data in a standard HL7 format and load that data into its prototype Janus Version 2 database. In addition to the Janus Version 2 database, FDA will also make use of enhanced analytical, mathematical, visualization and other computational tools and techniques that enable reviewers to search, model, and analyze data to conduct better safety and efficacy analyses.

When asked about the project, Jason Rock, CTO, GlobalSubmit said, “Our vision and the Agency’s vision are closely aligned in that both organizations want to improve the management of all structured scientific data, including standardized clinical study data. When realized, this shared vision will increase transparency for regulated products, leading to safer and more effective drugs being offered in the marketplace.”