Looking Ahead with Jan Klint Nielsen: CTMS at the Start of 2026

The start of a new year is a time to look forward to what’s ahead in our industry and organizations. In clinical trials, and especially in CTMS, that forward look is very concrete. The conversations we’re having with clients today are very different from the conversations we had even a few years ago. 

From my perspective, the biggest shift is simple to describe but significant in impact: clients are no longer asking for individual systems. Almost 90% need a combined CTMS and eTMF and that expectation now comes as a given. It’s no longer a future discussion; it’s the starting point. Integration is key. 

This change sits alongside a broader movement in the market. 2025 was the year with the most new clients in BSI Life Sciences and that growth is closely tied to digitization. Many organizations want to move away from what they have today and into more integrated setups. Digitization is ongoing and the motivation is clear: Sponsors and CROs want to be more efficient, to run trials more efficiently. 

As we begin 2026, these shifts are shaping what a CTMS needs to be: global, easy-to-use, compliant, and at enterprise scale. The question is no longer whether CTMS will change, but how it should support the people running clinical trials every day. 

What we see very clearly is the range of organizations making this move. New clients are coming from all over the world and from a variety of different life sciences organizations : biotech, pharma, diagnostics, and  global Clinical Research Organizations. CROs make up 40% of our clients. In 2025, we also saw an uptick in university hospitals. These organizations are actively moving away from setups that no longer efficiently support how they run trials today. 

This matters because trials are increasingly global. Expectations around systems are rising everywhere at the same time. That’s one reason integration has become such a strong theme. The market has started questioning existing approaches because they see that some vendors have 5-6 systems they’ve just workshopped together. The idea of an all-in-one CTMS and eTMF  isn’t just a marketing message anymore; it comes directly from what users are asking for. 

Our point of view is very clear: the future of CTMS is not about adding more tools, but about reducing friction for the people running trials. The market is moving away from collections of loosely connected systems because they slow teams down and make daily work harder than it needs to be. Clients are asking for one place to work, with integrated CTMS and eTMF, strong usability, and interfaces that actually help users get through their day. 

That is the direction we believe clinical operations technology is heading, and it’s the direction we are building toward at BSI Life Sciences.

The second topic that comes up in almost every conversation is AI. But the real focus isn’t AI on its own, it’s about how it helps users in their daily workflows. 

At BSI Life Sciences, finding the right use cases for AI is what matters. The first use case is the BSI Companion. AI can support end users in their daily tasks, in forecasting, in help, and in using and setting up the solution and trials, and in data analysis. The Companion, coming in the next release, is all about end user support. 

It’s not just about integrating AI; it’s about meaningful integration creating added value for the end users. Users are very clear about their needs. Many don’t have a lot of time for training; some might not be great with computers. They need systems that are easy to use. AI should support the user and make the system friendlier, not add more complexity. This is what the BSI Companion will provide.

Of course, data safety is the top priority. Any use of AI must meet data protection and privacy standards in the EU, ensuring that it’s patient-secure and GDPR compliant. These topics are central in every discussion we have, internally and with clients.

When we look at why we’re winning new clients, the same answer comes back again and again: it’s about usability. This applies across all types of organizations  we work with. People want systems that efficiently fit with their day-to-day responsibilities. 

This focus on usability is closely connected to integration. Integration isn’t only technical, it’s also about how users experience the platform as a whole. This is why partnerships are becoming more important. To be able to deliver a complete platform, not as a single vendor but as a partnership, collaborating with our technology partners and our clients. 

As we move into 2026, this becomes even more important. We’re building global partnerships with other technology vendors and with global acting life science consultancy companies alike to multiply reach, provide local support, and tighten compliance across the world. 

As we move into 2026, three things stand out to me. 

First, exciting news: we’re going live with one of the top five pharma companies in the world. We’re continuing to onboard and work closely with large enterprises, with all the scale and complexity that comes with that process while continuing to support small- and mid-sized companies. 

Second, we look forward to meeting industry colleagues and clients at conferences throughout the year. We’re kicking off 2026 by attending SCOPE in Orlando Florida during the first week of February. We’ll see you there! 

Finally, the BSI AI Companion will provide end user support and at this level changes how people interact with the BSI CTMS in their daily work. Streamlining documentation, answering workflow questions in real-time, analyzing data, and changing configurations will be easier than ever.

CTMS comes with a fully integrated eTMF and smooth integrations to other required eClinical systems e.g. EDC. It’s the central platform for running clinical trials across regions, countries and organizations. At BSI Life Sciences, our role is to grow with that reality by focusing on functionality, usability, integration, compliance, partnerships and global reach. 

2026 is about building on what our clients are already asking for, and delivering it at enterprise scale.

Cheers to the year ahead!

Jan Klint Nielsen
Managing Director
BSI Life Sciences