Clinical Trial Management System (CTMS)
To ensure product safety and effectiveness, life sciences companies conduct clinical trials — a costly, time-consuming part of the product development process. An unreliable CTMS can jeopardize time to market and study subjects’ safety. The life science industry is turning to CTMS software to optimize and integrate trial processes and improve visibility into clinical activities.
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CQMS Solutions
The effectiveness of a clinical quality management system (CQMS) can be evaluated by its capability to connect information and assess its impact. MasterControl CQMS™ streamlines the management of all the electronic trial master file (eTMF) documents, activities, projects, processes, quality events, relationships, audits and training that must be administered throughout a clinical trial. MasterControl CQMS is a complete solution that facilitates efficiency and the reuse of information while expediting clinical processes and tasks. Unlike a traditional CTMS that focuses only on data collection, MasterControl combines CTMS and CQMS to holistically manage clinical documentation, quality and risk.
Clinical Management Challenges |
MasterControl Clinical Software Solutions |
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Effectively managing the enormous volume of documents, artifacts and information that comprise a complete TMF is a complicated and error-prone endeavor. |
MasterControl’s TMF Reference Model JumpStart configuration is based on the industry-recognized Drug Information Association (DIA) TMF Reference Model. The standardized format facilitates thoroughness and provides a uniform, centralized blueprint for organizing TMF documents. |
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It’s difficult to transfer high-volume batches of information and content to and from CROs, sponsors and clinical sites. Exchanging large batches internally is equally as challenging. |
MasterControl provides several methods for importing and exporting batches of content to and from the clinical management system. The streamlined exchange of information simplifies interactions and strengthens relationships with sponsors and CROs. |
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Attempting to effectively oversee the flood of documents, tasks and processes involved in a clinical trial is overwhelming. |
The project management capabilities built into MasterControl allow project leads to comprehensively manage all clinical activities. MasterControl clinical management software provides automated task reminders, milestones and updates as tasks are completed and promoted through various life cycles. |
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Managing site information, documentation and trial eligibility information for multiple clinical studies — often from hundreds of sites — is inherently problematic. |
With MasterControl clinical software, each site’s information can be linked, reported on and extensively searched. This includes information on monitoring visits, study participation, study qualifications and audit histories. |
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GCP training is essential, but difficult to track accurately. Maintaining compliant GCP training records is especially grueling with manual, paper-based systems. |
With MasterControl clinical software systems, training can be customized by user role and methods used (virtual class, ad hoc, etc.) and administered with proficiency tools like tests, quizzes and questionnaires. Training tasks are auditable and can be scheduled automatically. |
CTMS with Clinical Trial Documentation
During the course of a clinical trial, the amount of documentation that must be controlled and coordinated is voluminous and countless associated processes and tasks are required. To be competitive, life sciences companies continually look to increase efficiencies and cut costs at every phase of their clinical trials. Implementing an automated CTMS is a logical first step toward achieving those goals.
MasterControl Integrations
By integrating processes and documentation from all essential clinical areas, MasterControl clinical trial management systems automate and streamline all study, site, project, audit, quality event, risk and training management activities.
MasterControl’s robust document management functionalities greatly simplify GCP document control, eTMF management, document exchange and third party collaboration while also automating training task deployment. The clinical management software’s vendor management capabilities also make it easier to coordinate and work with contract research organizations (CROs), distributors, and other external groups.
Features and Benefits of the MasterControl CTMS
MasterControl CTMS is the ideal platform for managing clinical trials.
- TMF Document Management MasterControl’s web-based repository makes it easy to search for, retrieve and track documents. The system provides complete document change control for standard operating procedures (SOPs) and GCP compliance documentation.
- GCP Training Management Dramatically accelerate training programs with MasterControl CTMS functionality that offers automated training task notifications and dissemination of materials (documents, audio or video) as well as configurable testing options.
- TMF Project Management MasterControl clinical software includes a TMF Reference Model-based project plan template that enables documents or tasks to be managed as projects. The system automatically sends task reminders and updates as tasks are completed.
- Industry Standard Because MasterControl’s TMF Reference Model JumpStart is rooted in the industry’s premier TMF framework, it maintains clinical trial data and artifacts in alignment with best practices and ensures documentation completeness.
- Site Management Site-specific documentation like protocol amendments, site qualification information, study updates, investigator files and institutional review board (IRB) documents can be efficiently handled by MasterControl clinical software systems.
- Third-Party Access The Guest Connect portal to the clinical management system simplifies document exchange and collaborations with external partners like vendors and CROs. The tool includes notification, task assignment and redlining capabilities.
- Clinical Process Management MasterControl CTMS streamlines deviation, corrective and preventive action (CAPA) and other compliance-critical processes. It also enables users to quickly create forms and checklists that simplify the management of clinical quality processes.
- Easy Implementation The combination of the standardized TMF Reference Model configuration and MasterControl’s renowned time-saving validation decreases implementation times, improves user adoption rates and reduces learning curves.
- GCP Audit Management Study procedures, patient recruitment requirements, case report forms and visit reports can all be monitored and audited within the system. Audit scheduling and related task assignments can be automated to ensure nothing is overlooked.
- Mobile Access Users can maximize efficiency and productivity by accessing information and performing tasks from any location and at any time via their mobile devices.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
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To learn more about MasterControl's software systems, please contact a MasterControl representative.
