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.”
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.