Clinical trials as a strategic lever: what biotech startups often miss — quest column
Clinical trials can serve as a key strategic asset for biotech or medtech startups. With early, thoughtful design and execution, trials can accelerate innovation, build investor confidence, and increase valuation.
In a guest column for AIN, Wojciech Kula, CEO of Axcellant, a Contract Research Organization (CRO) that helps pharmaceutical, biotech, and medtech companies plan and execute clinical trials that lead to successful registration advised how to approach them while avoiding the mistakes most often made by startups and make them a real strategic lever with investors and the market is.
What are the most common mistakes?
Startups tend to be overly optimistic when it comes to the timeframe of clinical trials, both in terms of preparation and execution, as well as in terms of cost. In other words, they assume that it will be possible to complete clinical trials more quickly and at a lower cost.
Even large companies that employ dozens of people struggle to conduct clinical trials independently.
“Many companies believe that clinical research can be handled by individuals who do something else daily. Again, this is a mistake that only leads to frustration, as communication problems arise and decisions are delayed. At the same time, it does not make sense to launch a separate unit for clinical research if you plan to lead one or two projects. Especially in startups, which, due to their stage of development, always face shortages in human and financial resources,” adds Wojciech Kula.
Why are clinical trials so complex?
The clinical trial process is complicated mainly because you have to anticipate risks, solve problems, and often adapt to changes during the trial itself.
“Clinical trials are a dynamic process. Just as it is possible to compare some phases of clinical trials in other similar projects, it is hard to predict how the recruitment of centers and patients to the trial will proceed. In other words, we can draw on concepts and strategies in different projects. Still, the practical aspect is challenging to fit into a rigid framework immediately.
Elements such as contracting study centers and recruiting patients are dependent on external factors. Even the attitude, ambition, or even personal problems of the study team members who conduct the studies have an impact on their efficiency and success,” says Wojciech Kula.
You can spend as much time as necessary planning a clinical trial, including gaining a thorough understanding of the business environment and the medical background of the indication, as well as the application of the medical device or drug under development. A good clinical trial has a clear objective from the outset, is well-planned, involves consultation with regulators, and includes input from clinicians.
“My experience is that the more time we spend on planning and the more people we include in the review process – clinicians, practitioners, and even those from different markets – the better. It’s also worth including consultations with the relevant regulatory agency, such as the FDA or EMA, depending on your strategy.
This significantly increases the likelihood of research success and, ultimately, the registration of the product or drug. It’s advisable to include this step in your timelines from the outset. It would be advisable to begin with the FDA. They are generally faster at these consultations before the study starts than the EMA. So in Europe, we need to secure more time for such a process,” advises Wojciech Kula.
What are investors looking at?
A professionally planned clinical trial can serve as a strong argument in discussions with investors. They can examine the experience of the people who create the study plan and documentation. Involving an experienced CRO here can be an advantage over other projects.
“If I were an investor myself, I would first talk to a key opinion leader in a particular area, such as a doctor or scientist, and ask if they see a sense and a real need for patients in the field. Next, I would examine who within the company is responsible for conducting clinical trials.
I would pay attention to three key people – the biostatistician, who plans a meaningful patient population to prove the thesis; the medical advisor, who looks after the topic from the medical side; and finally, the clinical operations director, who is supposed to see what a clinical trial looks like, what challenges to expect in the process and whether the project is doable at all,” Wojciech Kula concludes.
As for the application of AI in clinical trials, its potential is most evident in data analysis, predicting trends, and supporting administrative processes, also known as regulatory intelligence. We are already testing solutions that can not only review the study plan but compare it with an extensive database of projects to determine whether repetitive elements of documentation required by regulators are correctly included. However, this is still not the stage at which we can design and conduct an entire clinical trial step-by-step with the help of AI.
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https://en.ain.ua/2025/07/07/clinical-trials-as-a-strategic-lever/