The MasterControl CQMS™ Clinical Solution Package includes three (3) out-of-the-box clinical monitoring templates. These clinical monitoring forms are electronic forms designed to be used by a clinical monitor when conducting clinical site monitoring visits. Based on the type of visit, each form will focus on various different aspects of verification of information throughout the clinical trial.
Clinical Monitoring Challenges
MasterControl Clinical Monitoring Solution
|Designing monitoring plans and supporting documentation targeting areas of risk on a study by study basis.||MasterControl Clinical Solution Packages are designed to be configurable on a study by study basis. Configurability enables study teams to design monitoring checklists/forms focused on areas of risk as identified in a risk management plan for a study.|
|Ensuring consistency in monitoring activities across all clinical monitors to ensure consistence throughout the review of site activities.||The use of MasterControl monitoring visit forms across clinical monitoring teams ensures that all monitors will work off of the same checklists and that required form fields are prepopulated as part of regular monitoring activities. This results in more complete data collection and better quality of data for tracking and trending.|
|Identify and follow-up on findings during monitoring visits to ensure closeout of action items between monitoring visits.||MasterControl Clinical Solution Packages are embedded with “action item tasks” that can be launched throughout various steps of monitoring. These action item tasks are automatically sent to the assigned users’ tasks list. They can include due dates and instructions and will be linked to the originating monitoring visit report.|
|Ability to easily access all past monitoring visits and open action items from visit to visit to ensure follow-up and updates.||MasterControl Clinical Solution Packages include out-of-the-box report templates that enable tracking and trending across products, studies, and sites including open tasks, assignees and more. Additionally, as subsequent monitoring visits are conducted, open data (i.e., action items and notes) can be linked to new monitoring visit reports to provide transparency between visits.|
|Ability to link monitoring visit reports across visits, sites and studies for reporting, analytics and tracking and trending.||MasterControl Clinical Solution Packages include out-of-the-box report templates that enable tracking and trending across products, studies and sites.|
|Ability to link monitoring reports to protocol deviations and clinical corrective and preventative actions (CAPA) for issues raised across sites and studies. ||MasterControl Clinical Solution Packages are fully integrated monitoring, protocol deviation and clinical CAPA quality event management solutions with standardized data designed to facilitate the ability to analyze and report on quality trends and statistics.|
For more information about our clinical management software systems and jumpstart options, please feel free to contact a MasterControl representative.