Clinical Trial Management Systems
Today, more and more companies are looking to clinical trials management system (CTMS) applications to streamline their clinical development operations. When selected and implemented properly, a CTMS can help users efficiently and more effectively manage multiple trials around the world.
A CTMS not only allows for the tracking of activities and results with access to real-time information, it can also eliminate the need for ad hoc systems, one-off spreadsheets, and individual approaches to trial management. In short, it can enable efficiencies that just weren't possible before.
USDM has a proven record of ensuring that our clientele's Clinical Trials Management System (CTMS) applications collect and manage clinical data reliably, efficiently and in compliance with government regulations and industry best practices.
Examples of CTMS applications that our USDM consulting professionals have successfully validated include:
In addition to hands-on experience in one or more CTMS applications, our USDM consulting professionals have in-depth knowledge and expertise in the following:
- FDA regulations (e.g., 21 CFR Parts 11, 210, 211 and 820) relevant to CTMS
cGXP (i.e., GLP, GCP and GMP) - Development of validation documentation packages and SOPs
- Execution of validation/qualification protocols and test plans.
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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