What 2025 Taught Us About Clinical Trial Complexity and What We're Taking Into 2026

There's a moment every year when you step back and realize just how much the ground has shifted beneath your feet. For me, 2025 was full of those moments. 

I've spent this year in conversations with sponsors, CROs, and our own team here at Trial Interactive, and one theme kept surfacing: clinical trial complexity isn't slowing down. If anything, it's accelerating. The real surprise was how our customers responded. 

The Honest Admission That Changed Everything 

Here's what I didn't expect: clients started admitting to us they needed more help than they originally thought. 

For years, there was an assumption that once you implement a new technology, whether that's an eTMF, CTMS or another clinical trial technology solution, the hard part is over. But 2025 proved otherwise. Clients realized that while you can have a shiny new platform, it's really the process and the people that determine success. 

Change management became the conversation. Training became the priority. And the financial investment in proper onboarding and support stopped being seen as optional and started being recognized as essential for long-term success. 

That shift in mindset was refreshing. It opened the door to deeper partnerships and better outcomes. 

From eTMF to Platform: The Evolution Nobody Saw Coming 

For a long time, eTMF was the buzzword. It was what everyone needed, or thought they needed. 

But something changed this year. I can point to four or five projects where clients came to us and said, "We need more than just document management. We need CTMS. We need an LMS for site and study team training. We need these systems to talk to each other." 

The realization hit: from trial execution to close-out, sponsors need multiple solutions working together. Those trackers and siloed systems are not cutting it anymore, and haven’t for many years. Clinical trial complexity demands a platform approach: one place where all your study information lives and connects. 

One client we worked with this year integrated five different external systems into our platform through connectors. Five. That's data from various sources flowing into a single source of truth. It's a glimpse of where we're headed: Trial Interactive as the hub where everything comes together, an aggregator. 

The Regulatory Wake-Up Call 

If there's one area where I saw sponsors and CROs struggle, it was keeping up with evolving regulations, particularly the new ICH guidelines. 

Sponsor oversight expectations are clearer now than they've ever been. But clarity doesn't mean simplicity. Many of our clients are so busy running their studies day to day that they don't always have the bandwidth to digest what's coming and what it means for them and their organizations. 

That's where we've tried to step up. Whether it's through our services, our technology, or both, we've been pushing clients to fully leverage what we offer. Not because it's good for us, but because it's going to matter when regulatory inspections or investment partners come into the picture. 

What We Invested In (Even When It Wasn't Flashy) 

I'm very proud of the work we did this year on our quality management system (QMS) solution, which is part of the Trial Interactive platform. 

We had an early version before, but it wasn't fully baked and lacked some of the features our clients needed. This year, we committed real resources to building out a true QMS. It's designed especially for emerging biotechs and smaller sponsors in a regulated industry who need something turnkey, with workflows they can configure and leverage without starting from scratch. 

It's not the kind of investment that makes headlines. But it's the kind that makes a difference. 

The AI Question Everyone's Asking 

Here's the thing about AI: everybody has an initiative. Every company, every department, every conference panel. But for smaller sponsors who are busy running studies and chasing funding, there isn’t always the bandwidth to figure out how AI fits into their operations. 

We've been learning from partners who understand AI deeply, and we're seeing real benefits in how we apply it to clinical trial workflows. The opportunity now is helping more clients take advantage of what's already possible. Not the hype, but practical applications that actually reduce burden and improve efficiency. Partnering with our clients to demonstrate those benefits now and in 2026 continues to drive our approach to change management and streamlining clinical studies.  

The Hard Lesson About Onboarding 

If there's one lesson from 2025 that didn't come easy, it's this: onboarding is harder than it looks, especially with smaller sponsors. 

Turnover happens. People leave. New staff come on board. And every time that happens, you're potentially starting over with new stakeholder engagement, new opinions and perspectives, and new training. We've evolved our onboarding process to make it more efficient and create a better experience, but it remains a partnership. We bring best-practice consulting. Clients bring commitment to getting things completed and signed off. 

In a regulated environment, there's no shortcut. But there can be a better path. 

Looking Ahead to 2026 

So what would I tell our customers heading into next year? 

Partner with us differently. We have a wealth of experience running and executing clinical trials on our team. Don't just see us as a technology vendor. See us as collaborators and a true partner with more than 30 years of clinical trial experience who can help you think through your challenges, whether they involve technology, services, or both. 

If you're struggling with sponsor oversight, vendor management, or simply figuring out how to make your studies run more smoothly, raise the flag. Talk to us. To directors and clinical operations leaders, have a conversation with us about what's keeping you up at night. We’re in the same boat and can help leverage best practices across similarly sized sponsors and CROs. 

You might be surprised at how much we can help beyond what's written on paper. We have knowledgeable people who've run studies for decades. We understand AI in the context of clinical trials. And we're ready to bring that perspective and experience to whatever you're facing in 2026. Some of our best partners begin when clients reach out and say, “We have this challenge and wanted to brainstorm to see if you might be able to help.” Those are the conversations we value most, because they help all of us move the clinical development landscape forward. 

Ready to tackle clinical trial complexity head-on? Contact Trial Interactive to start a conversation about your 2026 goals.