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Combined eTMF and CTMS: The Smart Move for Clinical Trials

Switching to a CTMS with an integrated eTMF is the smartest choice on the market: smooth, streamlined data transfer, no sync time, and speedy inspections.

Switching to a modern Clinical Trial Management System is a big decision, but choosing one that combines a CTMS with an eTMF? That’s a smart one. 

The CTMS market size was estimated at $1.85 billion in 2024, projected to grow at a CAGR of 14.65% from 2024-2030. We’re seeing a ton of options flood the market as companies expand and move away from legacy systems. As trial teams look for ways to cut down on time, reduce risk, and keep it all in one place, moving to a combined platform’s the best step forward. 

It’s common sense: a system that brings together trial and document management makes daily work more connected and less time-consuming. But how does that work in practice? Let’s break it down. 

Benefits of a Combined CTMS and eTMF

When your CTMS and eTMF are part of the same system, your teams don’t have to jump between tools or transfer information manually. Study tracking and documentation exist in the same environment. You don’t have to wait for syncs. Updates are always matched. And there’s absolutely no double data entry. 

The setup gives clinical teams one system to manage investigator sites, plan and monitor visits, track milestones, and handle compliance docs. Everything happens at the same time. There’s less back and forth and fewer delays across the board. 

It also makes collaboration easier. Whether you’re on the sponsor side, part of a CRO, or handling site-level tasks, everyone sees the same information in real time. This, in turn, improves accuracy and cuts down on the errors that happen when people work in separate systems. 

Why It Matters for Study Teams

Having a modern CTMS and eTMF in one system saves time, yes—but it also helps teams stay audit-ready. With built-in workflows that support both operational and regulatory tasks, it’s easier to stay on track. 

When monitoring visits are recorded in the CTMS, the visit reports, follow-up letters, and action items immediately connect to the right folders in the eTMF. The system logs actions automatically, with version control and timestamping already in place. This translates to less worry about compliance and more focus on what actually matters: keeping the trial running smoothly. 

Document filing also becomes more reliable. Instead of uploading to an external eTMF, teams can file directly from the platform they’re using to run the study. It’s all right there: connected, clean, and current.

Cut Out the Integration Headaches

Working with a CTMS that not only supports integrations and interoperability but has an integrated eTMF simplifies the whole workflow. It takes away that back and forth, relying on two separate systems to share information. That connection can be fragile! What if it breaks during a software update? What if your teams forget to double-check a sync? Either way, you’re left with inconsistencies that slow down your work and put data at risk. 

Having a combined CTMS and eTMF in one platform is such a game-changer. Instead of patching systems together with APIs or middleware, everything’s built to function as a unit. The eTMF automatically reflects study updates. Monitoring reports link directly to the right documents. Audit trails stay complete without extra effort. 

You’re also never stuck building out custom configurations or chasing down compatibility issues. There’s no delay between data entry in the CTMS and the associated document record in the eTMF: it’s all recorded in real time. For teams trying to meet deadlines and stay compliant, those saved hours add up quickly. 

And when you consider regulatory inspections, the benefits multiply. A system that captures links and operational data in one place gives inspectors a clearer picture of your trial conduct. You don’t have to pull evidence from multiple systems or explain why versions don’t match. Inspections become smooth and streamlined.

One Vendor, One Support Team

Using separate vendors for your CTMS and eTMF tools often means managing two entirely different support structures. This translates to different ticketing systems, different timelines for fixes, different approaches to CTMS user training and updates. And when issues overlap between systems, it can lead to finger-pointing and delays in finding resolutions. 

With a unified CTMS and eTMF, you’re working with one vendor—full stop. You’ll have one point of contact for questions, one shared knowledge base, and one consistent approach to customer service. 

It also means that your support team understands the full system. They won’t just troubleshoot one module; they know your system inside and out.  Document workflows connect to your study timeline, monitoring reports trigger document tasks, filing compliance ties into user permissions and audit readiness. 

You’ll also have a more practical approach to training. Your team won’t have to learn two separate systems; there’s a more holistic approach possible. Your vendor can train each team on how the system supports their specific roles. This speeds up onboarding and cuts down on errors once trials are underway. 

It’s a no-brainer. A combined CTMS and eTMF offers a simpler, cleaner way to run trials—and that peace of mind is just as important as any feature list. 

Looking for the smoothest migration on the market? Switch to BSI CTMS.

BSI CTMS is top of the line and we have the track record to prove it. Our modern CTMS solutions cover all aspects of your clinical trials and we want you to test them for your team!

BSI’s CTMS is the most innovative, function-complete, and easy-to-use clinical trial management software on the market. It provides CTMS, eTMF, Study Startup and Trial Supply Management in one integrated, unified platform.

Standard interfaces (API) assure complete data oversight and easy integration with the external systems (e.g. EDC and eTMF) of your choice. The BSI CTMS is the central hub for all aspects of your clinical trials. It’s available as SaaS for ease of use, continuous improvement, and simplified infrastructure.

We’re modern, sleek, and designed with the user in mind for intuitive end-to-end clinical trial management. And the best part? We offer updates, upgrades, and scalability in-house with a full client support team for your legacy system migration and beyond. 

There’s never been a better time to embrace a better CTMS. Book a call today! 

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Jan Nielsen
BSI Life Sciences Community Manager

+41 58 255 96 22
jan.nielsen@bsi-software.com