During the development of a typical product, the management of clinical trials can be one of the most costly and time consuming components of the development process. Managing clinical trial data with paper-based systems slows down an already tedious process. A proven clinical trial management software system can streamline document management processes and provide instant access to critical clinical trial documentation.
The number of different groups involved in a clinical trial is only exceeded only by the overwhelming number of documents, processes, and tasks that must be executed and managed during the course of the trial. To keep up with these workloads and stay competitive a company must find ways to cut costs and increase efficiencies at each step of the clinical trial. A clinical trial management software system can be an invaluable efficiency-building tool your company can implement as you endeavor to achieve these goals.
The MasterControl Clinical Suite 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 trial management software system designed to streamline and increase reuse of information while simplifying the processes and tasks that need to be executed during the lifespan of a clinical trial.
During the course of a clinical trial there are countless hurdles that seem nearly impossible to overcome when utilizing outdated legacy systems. For instance, consider the inherent complications of importing and exporting high value batches from various sources (internal, CROs, clinical sites, etc.). An effective clinical trial management software system - such as the solution offered by MasterControl - can provide many simple and practical methods for batch importing and exporting of content to/from the system.
Managing all of the documents, tasks, and processes during the life of a clinical trial can be overwhelming and the sheer volume of documents that comprise a clinical trial master file add difficulties of exponential proportions. The MasterControl clinical trial management software system's TMF project management capability allows a user to plan TMF documents and tasks as a Project with automated task reminders and updates that are generated when tasks are executed and promoted though various lifecycles. In addition, the MasterControl Reference Model - TMF JumpStart configuration is based on the DIA Reference Model. Using this model increases efficiency and provides a central location for all required TMF documents.
The management of site documentation and trial eligibility information from hundreds of sites for various clinical studies creates added headaches during clinical trials as well. With MasterControl's clinical trial management software system, 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.
Document Types, Metadata, and Taxonomy based on the Drug Information Association's (DIA) Trial Master File (TMF) Reference Model, Workflow Routes, Collaboration, and Electronic Signatures.
GCP Trial Initiation, Closeout, Clinical CAPA.
Project Plan Template based on the DIA TMF Reference Model. Integrated Project Tasks: Documents, Processes, etc.
Site Information (Facilities, Equipment, Audit History) and Documentation.
Clinical Site and Partner (i.e., CRO, CMO) Audits.
Configurable Test/Quiz Setup.
Access Documents, Processes, Tasks, and Training Courses from tablets or smartphones.
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