The standards focus in many of yesterday's DIA announcements continued today. Phase Forward has announced availability of WebSDM Release 3.0, a tool developed under a cooperative R&D agreement for the FDA to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format. WebSDM now includes support for checking data submitted in CDISC SDTM version 3.1.2 format. It also includes updates to edit checks for earlier SDTM versions, as well as the ability to generate define.xml files from SDTM datasets.
The company also unveiled Empirica Study, formerly the Clinical Trials Signal Detection product (CTSD), as part of the Empirica Suite. The solution helps clinical and safety teams understand a product's emerging safety profile during clinical development by detecting safety issues and providing for their review and analysis.
Phase Forward announced yesterday a new release of its flagship electronic data capture solution for clinical trials, the InForm Global Trial Management e-clinical product. The scope of the company's offerings-InForm GTM, the Empirica Suite, Clarix interactive response technology for randomization and trial supply management, plus the recently acquired Waban Software platform for safety data management and analysis-now spans the clinical trail process, the company says.