(Sparta Systems: Holmdel, NJ) --  Sparta Systems Inc., the maker of TrackWise software and a provider of enterprise quality and compliance management solutions, is pleased to announce new additions to the TrackWise Electronic Regulatory Reporting (e-reporting) solution to support reporting in the ClinicalTrials.gov and the medical device vigilance reporting. The addition of ClinicalTrials.gov reporting enables companies conducting clinical trials to streamline protocol registration and trial results reporting in accordance with U. S. Food and Drug Administration (FDA) requirements. The solution also supports Medical Device Vigilance System reporting to European health authorities that will become a mandate in the first quarter of 2010 for the German Federal Institute for Drugs and Medical Devices (BfArM) with other European agencies to follow suit.

 …