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.”
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.