An adverse drug event within the FDA environment refers to any undesirable change in health that occurs in a person after they have enrolled in a clinical trial. In order to monitor drug safety, the FDA requires that each adverse drug event be reported and reviewed by the Center for Drug Evaluation and Research (CDER). MasterControl Inc. provides GxP process management software solutions specifically designed to address the challenges of compliance within the rigorously regulated FDA environment.
MasterControl Inc. is a leading global provider of GxP process management software solutions. Since 1993, MasterControl has been providing FDA regulated companies with the software solutions they need to attain and sustain regulatory compliance. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, including safeguarding of adverse event reporting processes. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better GxP process management.
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