End-to-end Solution Provides Holistic Process Support for Oversight of Global Clinical Trials
HOLMDEL, N.J., June 22 /PRNewswire/ -- Sparta Systems, Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management, today announced the availability of TrackWise Clinical Quality Management Solution, providing an end-to-end system that streamlines the oversight of business-critical clinical trial processes and helps ensure compliance with global regulatory standards. This extension of the TrackWise enterprise quality management system (EQMS) drives organizational efficiencies beginning with pre-clinical activities through manufacturing and post-market operations.
Successful clinical trials are the lifeblood of a life sciences company, with expanding global operations making the effective planning, coordination, collaboration and oversight of these events a business-critical activity. As companies continue to expand their clinical operations to sites in dozens of countries, completion of these trials has quickly become the longest and most costly stage in the drug development process. This holistic approach for the oversight of quality and regulatory processes moves beyond the more typical subject-centric applications widely used today and helps to prevent costly and time consuming operational quality problems caused by a lack of oversight and control.
TrackWise Clinical Trial Quality Management Solution provides closed-loop process support to allow issues to be reconciled and corrected before they escalate. The solution manages incidents, structured audit programs specifically tailored around clinical trial execution, the associated CAPA and change control processes as well as trial registration and trial documentation/SOPs. With more than 15 years of life sciences expertise, Sparta Systems understands the needs of organizations in this market and has evolved TrackWise software to meet and exceed its customers' clinical quality management requirements.
"With the rapid globalization and ever-increasing expense of clinical trials, life sciences companies and contract research organizations have clinical operations in dozens of countries, while still needing to maintain the same high level of quality expected by regulatory authorities," said Mike Jovanis, vice president, product management at Sparta Systems. "We are excited to have brought many CROs onto our solution while at the same time extending the footprint of TrackWise software into the clinical operations of a broad range of our existing life sciences customers."
About Sparta Systems
Sparta Systems, Inc., is an 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 14 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 can be found at www.sparta-systems.com.
Sparta Systems and TrackWise are trademarks or registered trademarks of Sparta Systems, Inc. All other marks are trademarks of their respective companies.
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