SALT LAKE CITY, USA - March 7, 2012 - MasterControl Inc., a global provider of quality and document management solutions for companies doing business in regulatory environments, today announced the release of the new MasterControl Clinical Suite™. 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:
o Quality processes (i.e., deviations, Clinical CAPA)
o Site monitoring checklists/forms (for pre-trial, site initiation, interim and closeout)
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
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:
About MasterControlMasterControl Inc. 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 www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 81 (3) 5422 6665 (Japan).