eTMF Software Systems
A trial master file (TMF) contains essential documents and artifacts associated with a clinical trial which are subject to compliance with ICH GCP, FDA 21 CFR Part 11 and other regulatory requirements. The TMF must not only contain adequate and accurate data, but it must also be organized in a manner suitable for evaluation by inspectors, and sharing with clinical study team members both internally and externally. MasterControl goes beyond mere document management by providing an eTMF software system based on the TMF Reference Model that is designed to enable real-time visibility into the status of all activities pertaining to a clinical study.
The Value of a Compliant, Connected eTMF Software System
Managing thousands of clinical documents, tasks and processes using a paper-based or hybrid TMF system can be overwhelming and can introduce errors and oversights that put your clinical trial at risk for noncompliance. An eTMF software system can provide an industry best practice approach to document management which allows you to gain the insight you need to efficiently manage your clinical trials and accelerate your time to market. MasterControl's eTMF software systems are designed to effectively manage eTMF processes and integrate them with other quality processes critical to regulatory compliance.
Benefits of MasterControl eTMF Software
- Designed by Experts:MasterControl TMF JumpStart is a configuration that has been developed by MasterControl with the guidance of a member of the DIA SIAC. This configuration of document types and metadata based on the DIA TMF Reference Model was designed to promote a common configuration across the industry for clinical trial document management.
- Simple Implementation:Using the MasterControl TMF JumpStart decreases implementation time and ensures that companies get a more standard configuration.
- Mobile Access:External light users and mobile users can quickly access information in the clinical management software system 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).
Features of MasterControl eTMF Software
- MasterControl eTMF software systems include a configuration that has been developed by MasterControl with the guidance of a member of the DIA SIAC. This configuration of document types and metadata based on the DIA TMF Reference Model was designed to promote a common configuration across the industry for clinical trial document management.
- Using the MasterControl eTMF software system decreases implementation time and ensures that companies get a more standard configuration.
- External light users and mobile users can quickly access information in the clinical management software system 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).
- The MasterControl eTMF Reference Model configuration is based on the DIA Reference Model. Using this model will increase efficiency and provides a central location for all required TMF documents.
- MasterControl Taxonomy Explorers are designed to create folder structures based on metadata populated within each document to automate the placement and creation of electronic TMF Explorers.
- MasterControl provides various methods for batch importing and exporting of content to and from the clinical management system to facilitate the relationship between sponsors and CROs.
- MasterControl TMF includes predefined rights access configuration for sponsors, CROs and sites. Documents, as well as collections of documents, can be easily shared with internal and external partners.
- MasterControl GuestConnect feature of Documents allows a user to invite external parties to upload content into the system in a controlled method using a placeholder which must then be released by documentation manager upon verification.
- The MasterControl GuestConnect feature of Documents allows a user to invite system users as well as external parties to controlled "collaboration spaces," enabling them to work collaboratively on documents.
Automated TMF Explorers Based on Custom Fields
TMF Management Challenges |
MasterControl TMF Solution |
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Manging Documents Difficulty managing the high volume and granularity of all documents that make up a clinical trial master file. | Manging Documents The MasterControl TMF Reference Model 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. | |
Organization Organizing TMF documentation in a consistent structure to facilitate placement and location of information. |
Organization MasterControl Taxonomy Explorers are designed to create folder structures based on metadata populated within each document to automate the placement and creation of electronic TMF Explorers. | |
Transferring Transferring high volume batches of information and content to and from various sources (i.e., internal, CROs, sponsors, clinical sites). |
Transferring MasterControl provides various methods for batch importing and exporting of content to and from the clinical management system to facilitate the relationship between sponsors and CROs. | |
Sharing Sharing of critical study and site-related documentation with partners (i.e., sponsors and CROs) and sites as needed. |
Sharing MasterControl TMF includes predefined rights access configuration for sponsors, CROs and sites. Documents, as well as collections of documents, can be easily shared with internal and external partners. | |
Exchanging Exchanging documents between partners (i.e., sponsors and CROs) and sites in a controlled environment. |
Exchanging MasterControl GuestConnect® feature of Documents allows a user to invite external parties to upload content into the system in a controlled method using a placeholder which must then be released by documentation manager upon verification. | |
Collaboration Collaborating on, editing, reviewing and approving documents with both internal and external partners. |
Collaboration The MasterControl GuestConnect® feature of Documents allows a user to invite system users as well as external parties to controlled "collaboration spaces," enabling them to work collaboratively on documents. |
For More Information on MasterControl's Clinical Management Software Systems
For more information about our clinical management software systems and jumpstart options, please feel free to contact a MasterControl representative.
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.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
