MasterControl eTMF

MasterControl eTMF software solutions offer an industry best-practice approach to document management that empowers you with the insights needed to efficiently manage your clinical trials and accelerate products’ time to market. MasterControl’s eTMF systems effectively manage clinical processes and seamlessly integrate them with other compliance-critical quality processes.

TMF Management Challenges


MasterControl Advantages

Document Management Headaches
Managing the high volume and granularity of all the documents that make up a clinical trial master file is problematic.

Efficient Document Management
MasterControl’s eTMF JumpStart configuration is based on the industry-recognized TMF Reference Model. This standard format facilitates completeness and consistency and provides a blueprint for a successful TMF plan.

Audit Inept
When trial master file documents are scattered among different systems and paper files, it takes more time and effort to prepare for audits and inspections.

Audit Ready
MasterControl TMF software ensures your eTMF is automatically kept up to date and that it can provide a single source of truth on a continual basis.

Disorganized Content
It’s difficult to organize TMF documentation in a consistent format and central location that allows information to be properly placed and conveniently accessed.

Precisely Organized
The built-in MasterControl Taxonomy Explorers create folder structures based on metadata that is populated within each document. These electronic TMF tools simplify the organization of the TMF by automating the placement and creation of TMF folders.

Laborious Batch Transfers
Transferring high-volume batches of information and content back and forth between various sources (i.e., sponsors, clinical sites, internal teams, etc.) is overly complicated and often impractical.

Streamlined Transfers
MasterControl provides multiple methods for easily importing and exporting batches of content into and out of the eTMF system. The smooth exchange of information simplifies interactions between teams and with partners like sponsors and contract research organizations (CROs).

Document-Sharing Difficulties
Sharing critical study and site-related documentation with sites and third parties like sponsors and CROs is essential but cumbersome for everybody involved.

Seamless Sharing
MasterControl eTMF software solutions include predefined configurations that give access rights to sponsors, CROs and study sites. Documents and collections of documents can be shared easily among authorized internal and external groups.

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