Sparta Systems, Inc. to Speak on Compliance with FDA Clinical Registration Requirements at 2010 Drug Information Association Annual Meeting
Published: Jun 16, 2010
WHAT: Sparta Systems, Inc., the maker of TrackWise® software and the market leader in enterprise quality and compliance management solutions, today announced its upcoming presentation at DIA's Annual Meeting on Wednesday, June 16, 2010 from 12:00 p.m. -1:30 p.m. The session will outline a simple process for businesses to automate compliance with the FDA's ClinicalTrials.gov portal and demonstrate real-life examples of best practices for electronic submissions.
The FDA currently mandates that all companies register and report certain clinical trials data such as trials of drugs and biologics and/or medical devices through its ClinicalTrials.gov portal. Failure to accurately and efficiently report this data can result in severe monetary penalties, public notice of the non-compliance, potential withholding of National Institute of Health funds and possible sanctions from the FDA, any one of which can be crippling to a life science company's business operations. Using the versatile TrackWise eReporting platform, companies can now track, register and report vital clinical trials data with the FDA's electronic registration portal using an automated system.
WHO: Joe Goodman, Director, Solutions Consulting at Sparta Systems
WHEN: Wednesday, June 16, 12:00 p.m. 1:30 p.m.
WHERE: Walter E. Washington Convention Center
801 Mount Vernon Place, NW
Washington, DC 20001-3614
CONTACT: For information on TrackWise products or services, visit www.spartasystems.com.
About Sparta Systems:Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 15 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® software can be found at www.spartasystems.com.
Sparta Systems and TrackWise are trademarks or registered trademarks of Sparta Systems, Inc. All other marks are trademarks of their respective companies.
Mark Van Hook
Articulate Communications Inc.
212.255.0080, ext. 33
SOURCE Sparta Systems, Inc.