In the past, it was not uncommon for a medical device clinical trial to be conducted outside of the "mainstream" clinical research industry. However, as the FDA continues to place increasingly more focus on good clinical practices, device manufacturers are finding an increasing number of regulatory groups and guidelines involved with every medical device clinical trial. The integrated GxP process management solutions offered by MasterControl Inc. help navigate device developers through the complex path toward regulatory compliance.
Every medical device clinical trial is expressly designed to answer particular research questions. While searching for answers during the course of any medical device clinical trial, a tremendous amount of documentation is generated that must be properly controlled and managed. Effective document control and GxP process management are key factors in getting a medical device past trial stages and eventually to market. The proven software solutions available from MasterControl provide a central and secure document repository and insure that all documentation generated over the full span of a medical device clinical trial can be efficiently accessed, revised, and controlled within the confines of regulatory requirements.