The regulations for establishing, implementing, and maintaining GCP compliance can be overwhelming. Companies face many challenges in controlling required documentation and managing processes during clinical studies. With MasterControl, the processes involved in satisfying GCP compliance requirements can be simplified and streamlined.
For more than a decade, MasterControl has provided configurable, easy-to-use quality management software solutions that keep companies’ clinical quality processes connected and properly aligned with the most current GCP compliance requirements, such as the ICH GCP E6 R2 Addendum, which encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
GCP compliance requires companies to be compliant, connected, and complete.
Through automated quality business processes, MasterControl helps companies attain GCP compliance and sustain it year after year. MasterControl also provides the resources companies need to validate and maintain their software solution.
MasterControl connects users with the data and processes needed to see the "big picture" of clinical quality. MasterControl’s holistic approach facilitates collaboration and allows managers to view and monitor all clinical quality processes in real time.
MasterControl helps companies realize GCP compliance as a part of their everyday corporate culture, so every department across the enterprise can be assured that compliance is being maintained.
The MasterControl GCP JumpStart™ is a preconfigured document managementtool for clinical quality research areas who wish to implement a solution to create,edit, revise, approve, access and train on good clinical practice (GCP) to supportand ensure quality compliance of day-to-day operations in their clinical researchactivities.
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