There's a new reality for clinical trials.
At BIO and DIA this year, one message kept coming up across panels, meetings, even the hallway conversations:
"It’s time to compete."
This isn’t a future concern. It is a "now" issue. And for many in the industry, it’s starting to hurt.
For years, clinical development moved at a pace that was... acceptable. Science was slow. Regulations were complex. The industry had built-in reasons for delays, and that made sense.
But that’s changing. Fast.
Biotech isn’t just local anymore. It's Global competitiveness. Timelines are tighter. Expectations are higher. And while some are adjusting, others are already moving at full speed.
In this article, we dig into the three areas that now define clinical competitiveness:
Speed, global readiness, and technology (that actually saves time).
These aren’t nice-to-haves anymore. They’re the new baseline.
China’s Speed Advantage
Let’s start with a stat that stopped people in their tracks at BIO:
“In China, it takes 3.5 years to go from zero to reaching Phase 1 data.
In Europe? Six to seven years.”
That’s not a small difference. That’s twice the time. Remember that, in this industry, a few months can make or break a trial. A few years? That’s a whole cycle lost.
But speed is only half the story. The other part is scale.
For every promising molecule in the US or Europe, there are seven similar ones already in development in China.
Not hypotheticals. Real trials. Already in progress.
Add to that a system built for fast approvals and local investment and it’s clear: the race is on. And (too) many companies are still at the starting blocks.
Speed Isn’t Just Efficiency. It’s an Advantage
Sure, it is easy to blame regulation for slow timelines. But often, the biggest delays are internal.
Start-up documents bouncing between teams. Patient materials stuck waiting for translation. Processes that rely on people emailing PDFs back and forth.
On their own, these delays seem manageable. Together, they create a massive drag.
The CROs and sites that stand out today aren’t just more efficient. They are designed to move faster from day one. Sponsors choose them not just for output, but because they buy lead time. And lead time, in this space, is currency.
An important note: speed doesn’t mean rushing. It means removing friction before it starts.
Going Global? Act Like It.
Running global trials is nothing new. But many teams still treat it like an add-on, not a built-in capability. If Covid has taught us something it is that the action is happening on a global scale and that, increasingly, clinical research needs to be global (not only in geography but also in patient populations) from day one.
More regions, more patients, more impact! Yes. But also more blockers, of course:
Different rules. Different systems. Different workflows.
And still, too many rely on patched-together processes to get through.
If you’re emailing consent forms back and forth, translating documents one by one, and managing countries in silos, you’re not scaling. You’re surviving while calling it "internationalization".
True global readiness means:
Designing with localization in mind from the start
Standardizing documents that flex - or can easily be tuned - for different regions
Giving local teams the tools to act without waiting on HQ
And here, expansion isn’t the problem. And it's a common issue, regardless of industry, it’s expanding without the systems to support it.
AI: It’s Time to Get Practical
AI came up everywhere at BIO and DIA. But the conversation is finally shifting. From buzzwords and "AI" fatigue to actual tools and use cases.
(One of) the most talked-about examples?
The FDA full adoption of AI and how their review time dropped from 3 days to 6 minutes using said AI.
That’s not a small gain. That’s a different workflow entirely. And that's productivity (a solid 99.86% productivity gain if we look at the strict figures).
But, let's take one step back. We're not talking ChatGPT, Copilot, and co here, the AI used wasn’t for show or general use. It was built for a specific job and delivered actual time saved.
That’s what teams want now and that's what serious companies are developing:
Tools that help turn complex materials and protocols into plain English
Platforms that localize patient materials instantly and safely
Systems that cut out repeated manual work
We’re finally moving past the question of "should we use AI?".
Now, the focus is on what truly matters: Where does it actually help and are we ready to use it today?
Competitiveness Starts with the Right Questions
Speed, scale, technology, they’re all connected.
You can’t grow without structure. You can’t go faster without systems (Speed without control = crash).
And without both, competitiveness becomes just a another fancy buzzword.
So here’s the lens every team needs to use:
Can we cut timelines without cutting corners?
Are our materials ready for localization, or are we scrambling every time?
Are teams sharing knowledge, or constantly recreating it from scratch?
Can a new partner understand our value in 10 minutes or do they need 10 days?
It’s not about being perfect. It’s about being ready to act, not just plan and hope.
The Clock Is Already Running
There's no question, the race has already started.
And if you're still brainstorming or reviewing your strategy, you're already behind.
This is the time for action:
Fixing broken processes.
Picking up the right tools.
Making faster, sharper decisions.
Competitiveness isn’t a layer you add later. It’s the foundation you build from. And if you haven’t done that yet? The gap is real. But still not impossible to close.
Just don’t wait. Because the others (AKA your competitors, known or upcoming), they’re already moving. Forward and fast!
