Clinical Study Software Systems


Proven clinical study software solutions allow organizations conducting clinical studies to conserve resources while accelerating products' time to market

With each passing day, clinical studies grow more costly, laborious, and time consuming. For organizations still using paper-based documentation systems, these challenges are compounded even further. If an electronic clinical study software system is implemented, all clinical study data can be easily stored and accessed in a central location, which increases efficiency and reduces wasted time and resources throughout the course of the entire clinical study.

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Eliminate Common Challenges with Clinical Study Software

There are innumerable clinical study obstacles that are practically impossible to overcome when the right set of tools aren't being used. Consider, for example, the difficulties inherent to importing and exporting high value batches from various sources (internal sources, CROs, clinical sites, etc.) without the utilization of an effectual clinical study software solution. A proven clinical study system like the solution offered by MasterControl can provide various straightforward and useful methods for batch importing and exporting of content to/from the system.

Effectively managing all of the documents, tasks, and processes during the life of a clinical study can be overwhelming. The crushing amounts of documents that comprise a clinical trial master file add a growing set of difficulties. MasterControl's clinical study software has built in TMF project management capabilities to let users plan TMF documents and tasks as Projects with automated task reminders and updates that are generated when tasks are executed through various lifecycles. Additionally, the MasterControl Reference Model - TMF JumpStart configuration is based on the DIA Reference Model. Incorporating this model increases efficiency and provides a central location for all required TMF documents.

Clinical Study Software Can Prevent You from Drowning In Paperwork

To keep pace with the overwhelming number of documents, processes, and tasks required to conduct a clinical study, an organization's decision makers must find ways to cut costs and increase efficiencies during each step of the process. Clinical study software can be integral to building an organization's efficiency and achieving its clinical study goals.

As the top specialized offering on the market, MasterControl Clinical Suite has been specifically engineered to manage all of the documents, tasks, processes, relationships, audits, and even training that needs to be administered and monitored throughout the life of a clinical study. The MasterControl Clinical Suite is a holistic and thorough clinical study software system designed to streamline the dissemination of and access to information while simplifying the processes and tasks that require completion during a clinical trial. MasterControl's software also guarantees that all such information is maintained in a central and secure web-based repository that is accessible only to authorized users.

Benefits of the MasterControl Clinical Study Software System

  • A Complete Clinical Study Software Solution: A clinical study pulls together myriad documents, tasks, and processes that are dependent upon one another and share common information. The MasterControl clinical study software system's integrated modules increase reuse and efficiency throughout the entire clinical study process.
  • DIA TMF Reference Model - Best Practices: The DIA TMF Reference Model has been adopted as an industry best practice standard for ensuring completeness of documentation for a clinical trial from both internal and external resources. MasterControl's incorporation of the DIA TMF Reference Model into its software not only ensures that studies remain in line with industry best practices, but it also enhances internal efficiencies according to established guidelines.
  • Efficient Management of Multiple Sites: The management of site documentation and trial eligibility information from hundreds of sites for various clinical studies creates a difficult juggling act. Information such as facilities, equipment, past trial participation, audit history, and other study-specific documentation all need to be accurately tracked and documented. With MasterControl's clinical study software, each clinical site's information and documents can be precisely linked, searched, and reported on.
  • Remote and Mobile Access: External light users and mobile users of the clinical study system can quickly access information critical to their roles (monitor, auditor, investigators) as well as enhance the flow of information and execution of tasks. This remote and mobile access reduces cycle time (i.e., review, approval, and training) and gives authorized users access to the software from virtually anywhere at any time.
  • Easy to Implement: Since most users are already familiar to some degree with the DIA TMF Reference Model, using MasterControl's Reference Model-TMF Jumpstart configuration decreases implementation and training time and allows companies to get the most standard configuration available. MasterControl is well regarded for being easy to implement, easy to validate, and easy to use.

Specific Solution Aspects of MasterControl's Clinical Study Software:

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 smartphones and tablets

For More Information on MasterControl's Clinical Study Software Systems

To learn more about MasterControl's clinical study software systems, feel free to contact MasterControl representative today.