Examining the Why and How of Integrating Your eTMF and CTMS

Adapted from a Phlexglobal Ask An Expert interactive discussion held May 11, 2022 and available on-demand here.  

Why Integrate Your CTMS and eTMF Systems? 

A typical electronic Trial Master File (eTMF) system and Clinical Trial Management System (CTMS) overlap with regard to clinical trial content and data that must be stored in both. This overlap poses a challenge and an opportunity. The challenge is ensuring that the correct information is accessible to the right team members in a timely manner. The opportunity lies in the potential to integrate these systems to reduce redundant and duplicated effort, increase consistency and accuracy of content, and improve clinical operations efficiency.  

From a compliance perspective, the most important is data consistency and accuracy – although greater efficiency also helps teams focus more effort on key compliance issues such as quality review. Records should have the same meaning, regardless of system. This data tells a story about the clinical trial, and the story should not vary depending on which system you access!  

Integration can also lead to process efficiency. When clinical professionals move data manually (e.g. export, email, import, repeat) from one system to another, the value of the automated system is decreased. As opportunities for human error are inserted into the process, the likelihood of incorrect, missing, or duplicate data grows. Replacing human actions with validated and automated processes for moving information from one system to another increases efficiency and data integrity. 

Clinical Trial Management Systems play an important role in tracking the progress of a clinical trial against a host of Key Performance Indicators (KPIs) such as completed site activation and site monitoring. These processes generate a significant amount of content that should also reside in the eTMF system. Rather than a cumbersome manual effort, moving or synching this content and data can today be automated - removing any risk of human error impacting the information as it moves between systems.  

Process Automation Ensures Timely Access to Information  

As life sciences teams take advantage of more automation and data integrations, expectations around the timeliness of documents and data can change. An effective integration of CTMS and eTMF systems makes the same content available in both systems in near real-time. Once the information is available, additional automations can produce reports or dashboards that are routinely updated and shared across global teams, improving inspection-readiness. TMF users can quickly and efficiently access approved reports without waiting for traditional slow, manual, and error-prone information sharing processes.  

Integrating a CTMS with an eTMF also requires less system-switching for users. They can work with familiar tools without logging in and out of multiple systems to complete their tasks. As users get comfortable with the integration, the simplified user experience will also support a new alignment of terms used across the business process. Team members can use the same language, refer to the same milestones, and work from the same data with minimal disruption to their daily work.  

CTMS and eTMF Content Sharing: How It Works In Practice  

Product information and clinical trial protocol information typically stored in the CTMS can be pushed to the eTMF. This can include metadata like the protocol number and title as well as the actual protocol document and any amendments. Study milestones and study-related documents and data flow into the eTMF, where it is readily available for operations teams and inspectors to better understand the “story” of the trial.  

In addition, as information is shared across systems and processes, the eTMF can push new and updated information back into the CTMS. Timely and accurate reports, status updates, and links to additional TMF content can be integrated into the CTMS, giving users a broader view and greater access to the emerging TMF content – while retaining the same picture in both systems.  

Opportunities on the Horizon 

In an informal poll during our webinar, only 3% of respondents had successfully integrated their CTMS and eTMF. When asked about their priorities in a CTMS integration, 39% of respondents chose automatic study/site creation and updating as the most important aspect. An additional 26% felt that automatically sending monitoring documents to the eTMF was the most critical aspect.  

It will be essential for clinical operations teams to learn from the experience of organizations that are further along in their CTMS-eTMF integration journey. We are already seeing companies reap the benefits of integration detailed here – and expect to see greater efficiencies, additional innovation, and more opportunities for improvement arise going forward. 

If you have questions about integrating a CTMS with an eTMF system, we’d be happy to share our extensive knowledge and experience. Simply contact us today to request a free consultation.