OmniComm Systems Delivers SDTM Tool
OmniComm Systems announced the early availability of its SDTM solution, which was developed for its flagship EDC product, TrialMaster. The SDTM allows for mapping and exporting of data directly into the CDISC SDTM format, ensuring an accelerated pathway towards electronic submission of clinical data.
OmniComm’s TrialMaster solution has supported the CDISC ODM, CDASH (including naming conventions and domain structures), HL7, E2B, and caBIG standards for years, and now CDISC SDTM. “TrialMaster™ offers an end-to-end solution from designing electronic case report forms (eCRFs) that support the CDASH naming conventions, to supporting the export of the CDISC submission format (SDTM), the preferred method for submission by the Food and Drug Administration,” commented Stephen Johnson, OmniComm’s COO, in a press release.
The product was originally scheduled for a 2010 release.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
