MasterControl, Inc

Clinical Management Software Systems


The management of clinical trials is one of the most costly and time consuming processes in the development of a typical product. An effective clinical management software system can help companies save time, money, and resources and accelerate time to market.

How Can Clinical Management Software Systems Help Your Organization?

The number of parties involved in a trial is only surpassed by the overwhelming number of documents, processes, and tasks that must be executed and managed. In order to stay competitive a company must find ways to reduce costs and increase efficiencies every step of the way. Clinical management software can be an invaluable tool for your company as you strive to achieve those ends.

The MasterControl Clinical Suite™, a clinical management software system, is designed to manage all of the documents, tasks, processes, relationships, audits, and training that must be administered and controlled throughout the life of a clinical trial. The MasterControl Clinical Suite is a complete clinical management software solution designed to increase efficiency and reuse of information while streamlining the processes and tasks that must be executed during the length of a clinical trial.

MasterControl's Clinical Management Software Provides Solutions For:

TMF Document Management - Document Management
- Document Types, Metadata, and Taxonomy based on the Drug Information Association's (DIA) Trial Master File (TMF) Reference Model
- Workflows: Routes, Collaboration, and Electronic Signatures
Clinical Processes Management - Process Management
- GCP: Trial Initiation, Closeout, Clinical CAPA
TMF Project Management - Project Management
- Project Plan Template based on the DIA TMF Reference Model
- Integrated Project Tasks: Documents, Processes, etc.
Clinical Site Management - Site Qualification and Relationship Management
- Site Information (Facilities, Equipment, Audit History) and Documentation
GCP Audit - Audits
- Clinical Site and Partner (i.e., CRO, CMO) Audits
GCP Training - Employee, Partner, and Investigator Training
- Configurable Test/Quiz Setup
Mobile Access
- Access Documents, Processes, Tasks, and Training Courses from tablets or smartphones

Clinical Management Challenges

Difficulty managing the high volume of documents that makes up a clinical trial master file.

Importing and exporting high value batches from various sources (i.e., internal, CRO, clinical site).

Management of all of the documents, tasks, and processes during the life of a clinical trial can be overwhelming.

Managing site documentation and trial eligibility information from hundreds of sites for various clinical studies.

Improve the quality of clinical data and reduce negative findings and open cases from audit findings.

Maintaining GCP Compliance training records

Clinical Management Software Solutions

The MasterControl Reference Model - TMF JumpStart configuration is based on the DIA Reference Model. Using this model will increase efficiency and provides a central location for all required TMF documents in the clinical management software.

MasterControl provides various methods for batch importing and exporting of content to/from the clinical management system.

The TMF project management capability in the clinical management software allows a user to plan their TMF documents and tasks as a Project with automated task reminders and updates as tasks are executed and promoted though various lifecycles.

With MasterControl, each clinical site's information and documents can be linked, searched, and reported on. This information includes facilities, equipment, past trial participation, and audit history as well as site- and study- specific documents.

Through the use of integrated processes, audits, and site information, quality tasks can be executed and closed out efficiently for increased compliance.

With MasterControl's clinical management software, training can be customized by user role and methods used (ad hoc, virtual class, etc.) and utilize proficiency tools such as questionnaires, tests, and quizzes. Training tasks can be audited and set for automatic scheduling.

Features and Benefits of MasterControl's Clinical Management Software

    • Complete Clinical Management Software Solution: A clinical trial involves various documents, tasks, and processes that are most often dependent upon each other and share common information. Integrated clinical management software modules increase reuse and efficiency throughout the clinical trial process.
    • Industry Recognized Best Practice: The DIA TMF Reference Model has been adopted as an industry best practice standard for ensuring completeness of documentation for a clinical trial from various resources both internal and external to an organization.
    • Simple Implementation: As many employees are familiar with the DIA TMF Reference Model, using MasterControl's Reference Model TMF Jumpstart configuration decreases implementation time, ensures that companies get a more standard configuration, and reduces the learning curve.
  • Mobile Access: External light users and mobile users can quickly access information in the clinical management software that is critical to their roles (monitor, auditor, investigators) as well as enhance the flow of information and execution of tasks, thereby reducing cycle time (i.e., review, approval, and training).

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