Cx

Clinical

eTMF Software Systems

An electronic trial master file (eTMF) software system minimizes the burden, risk and complexity by automating, centralizing and standardizing TMF processes.

An electronic trial master file (eTMF) is a trial master file that is in digital format and contains the essential data from a clinical trial that is subject to regulatory oversight.

Not only must a TMF contain accurate and compliant documentation, it must also be organized appropriately for evaluation by inspectors and sharing among study team members. MasterControl goes beyond basic document management by enabling real-time visibility into clinical study activities with an eTMF software system based on the TMF Reference Model.

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The Value of an eTMF System

Managing thousands of clinical documents, tasks and processes using paper-based or hybrid TMF systems can be overwhelming and may introduce errors or result in oversights that jeopardize your clinical trial’s compliance. 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 eTMF Solution

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.

Inefficient Document Exchange

The exchange of documents between partners (i.e., sponsors and CROs) and sites is risky and error-prone without a secure, controlled environment.

Expedient Exchange

MasterControl’s Guest Connect feature allows users to invite external parties to upload content into the eTMF system in a controlled manner using placeholders that can be released by the document manager upon verification.

Chaotic Collaboration

Collaborating on, editing, reviewing and approving documents with internal and external groups is cumbersome when everyone uses different systems.

Optimal Collaboration

With MasterControl’s eTMF systems, internal system users and external parties can be invited into a virtual collaboration space where they can collaborate on trial master file documents.

Moving Away from Paper to Software Systems

The inherent difficulties of using paper-based document management systems to handle literal tons of TMF documentation are increasingly leading organizations to switch to more effective eTMF software solutions. Electronic TMF management allows for a superior, efficient approach to document management and increases visibility into clinical trials. A reliable eTMF software system is an invaluable process management tool that integrates TMF-related activities with other compliance-critical quality functions.