MasterControl's Clinical Suite is a holistic solution designed to manage and maintain all of the documents, tasks, processes, relationships, audits, and training that must be administered and controlled throughout the life of a clinical trial.
"To stay competitive in the current market, regulated companies must do more with less and in less time," said Patricia Santos-Serrao, RAC, Senior Product Manager at MasterControl. "The MasterControl Clinical Suite is a unique solution that will provide a single source for managing clinical documents, collaborations, tasks, processes, training, audits, and site qualification information, resulting in increased transparency and compliance, which will reduce the overall cost of clinical research and time to market."
The MasterControl Clinical Suite includes solutions for:
• TMF Document Management - Document management configuration for Clinical Trial documents based on the DIA TMF Reference Model
• TMF Project Management - Project Plan for Trial Master File (TMF) documents based on the DIA TMF Reference Model
• Clinical Process Management - Includes best practice GCP Samples:
o Quality processes (i.e., deviations, Clinical CAPA);
o Site monitoring checklists/forms (for pre-trial, site initiation, interim and closeout).
• Clinical Site Management - Manage clinical site and study documents, study qualification criteria, and audit history from one location
• GCP Audit - Good Clinical Practice (GCP) Audit Management with sample GCP criteria question lists, audit execution resource management and more
• GCP Training - Good Clinical Practice (GCP) training execution including automated training based on updates, configurable aptitude testing
Clinical Risk Management - Manage risk throughout the life of a clinical trial with integrated risk management, reporting and analytics including:
o TMF Project: Timelines / Due Dates, Tasks Overdue, % Completion
o Procedures: Trial Monitoring - Enrollment, SAEs Clinical QA - Deviations, CAPA
o Site Mgmt: Investigator and Site Qualification, Audit History, Site Scorecard, etc.
o Audit: Violations, Finding, Deviations, Follow-up / Corrective Action
o Training: Completed, Outstanding, Overdue
• Mobile Access - Provide mobile access to documents, tasks and processes to Clinical Monitors and other mobile users.
The Clinical Suite solution includes document management and project management best practice configuration based on the Drug Information Association's (DIA) TMF Reference Model. The MasterControl Reference Model - TMF Jumpstart is made up of document types, project plans, metadata, and taxonomy developed by MasterControl with the guidance of industry experts and advice from members of the DIA SIAC. Using this model will help users easily manage the high volume of documents that make up a clinical trial master file, all in a central repository. In addition, the solution's TMF project management capability allows users to organize TMF documents and tasks as a Project, complete with automated task reminders and updates as tasks are executed through various lifecycles.
MasterControl Clinical Suite increases compliance by bringing together three major components of compliance: process management, audits and training. MasterControl facilitates the execution and closing out of quality tasks such as site monitoring and clinical CAPA as well as the execution and management of audits for various entities (CRO, Sites, etc.). Training tasks can also be customized by user role and methods used, and easily managed, executed, audited and automatically scheduled.
With MasterControl, each clinical site's information can be managed to include facilities, equipment, participation qualification, past trial participation, and audit history as well as site- and study- specific documentation.
Other beneficial features of MasterControl's Clinical Suite offering include:
• Decreased implementation time which reduces the learning curve and ensures that companies get a standardized configuration.
• Mobile access that allows for easy access to critical information, subsequently reducing cycle time.
• Industry recognized best practice standard, ensuring the completeness of clinical trial documentation.
• A complete clinical solution, designed to enhance transparency and reuse, thereby increasing efficiency and compliance throughout the clinical trial process.
MasterControl, Inc. (mastercontrol.com) produces software solutions that enable companies doing business in regulatory environments to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, eay to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submission documents management, clinical trial management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit the website or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 03-6801-6147 (Japan).