Europe’s clinical trials market is entering a more practical phase in its approach to competitiveness. With the Clinical Trials Regulation and the CTIS platform now in place, the conversation has shifted. It is no longer only about filing an application and securing approval. The more pressing question is how to design a study so that recruitment can begin quickly and smoothly once the decision arrives.
The ACT EU initiative captures this direction well. Europe wants more international trials, greater predictability, and a shorter path to the first patient recruited. For sponsors, CROs, sites, and their operational and regulatory partners, that means preparing projects far more thoroughly, and far earlier, than before.
This is not a theoretical adjustment. It changes how trials are run. In practice, what increasingly sets a study apart is the ability to fold regulatory strategy, site realities, the sponsor’s timeline, documentation, vendors, and the patient pathway into a single, coherent plan.
In a well-prepared study, many of the decisions that matter are made long before any documentation reaches the system. They cover country selection, site activation order, communication with investigators, division of responsibilities, the monitoring model, vendor management, and local requirements.
In practice, most delays do not trace back to a single dramatic problem. More often, they come from small things that were not connected early enough: underestimated site contracting time, local document checks that started too late, no clear escalation path, staff who were not sufficiently prepared, or the assumption that every country would move at the same pace.
“A well-run preparatory phase looks more like an operational project than a sequence of administrative steps, because each element shapes the next,” says Yana Arlouskaya, who works in clinical trial management at Axcellant. “If the feasibility analysis is too general, site activation becomes harder to predict. If local requirements are checked too late, answering questions from regulators or ethics committees can slow the entire timeline. And if vendors are not part of the planning from the very beginning, their readiness may not line up with the moment recruitment actually starts.”
In conversations about clinical trials, the term “site readiness” comes up constantly. In practice, it should be understood more broadly than a signed contract and a completed initiation visit.
A ready site understands the protocol, knows the patient pathway, has a confirmed team, documents its procedures, can access the infrastructure required by the study, and knows where to direct operational questions. In more complex studies, such as those involving specialized diagnostics, imaging, radiological procedures, or coordination across several hospital departments, readiness requires an additional layer of coordination.
Axcellant has run into exactly this. On one multi-country project, the team noticed that sites that were formally qualified differed markedly in their readiness to begin recruiting. The issue was not clinical competence. It was organizational: the availability of specific diagnostic procedures, internal hospital approvals, patient scheduling, and the flow of documentation between departments. It took a detailed conversation with each site to work out which could start sooner and which would need extra support.
That is a very practical lesson. Feasibility analysis should not stop at how many patients a site could recruit. It matters just as much whether the site can start on time and what conditions must be met to make that realistic.
Not every clinical trial is equally demanding to run. But some areas make the gap between plan and execution especially visible, and projects involving nuclear medicine or specialized diagnostic imaging are among them.
Studies like these call for attention not only to standard clinical processes but also to infrastructure availability, staff qualifications, laboratory schedules, radiation-protection requirements, local hospital procedures, and the documentation of results. Even when a trial does not involve a radiopharmaceutical as the investigational product, the mere presence of nuclear procedures or advanced imaging increases the complexity.
The key is to map the dependencies early. Who prepares the patient? When is the laboratory available? What does the referral pathway look like? Does the procedure require additional internal approvals? How is imaging data sent for central review? Are the technical staff and the investigator working to the same schedule?
These questions carry strategic weight. Asked too late, they can cause delays once a site is already active. Raised early, they can be built into the preparatory strategy and prevent unnecessary slippage.
The real challenge on one of Axcellant’s recent international projects was the gap between clinical competence and genuine operational readiness.
“We often say internally that a formally qualified site is only half the battle,” adds Yana Arlouskaya.
The challenge. Despite holding a complete set of documents and clearing the feasibility process, individual sites varied considerably in how quickly they put procedures in place. The obstacle was not medical knowledge but organization: an idiosyncratic flow of documentation between hospital departments, internal administrative authorizations, and limited access to critical diagnostic infrastructure within the required time windows.
Our approach: parallel workstreams. Rather than wait passively for the final regulatory decisions in CTIS, the Axcellant team set several operational workstreams running at once:
The result. With this approach, the regulatory decision was no longer the point at which practical launch planning began. It became a smooth handoff into the next stage of a plan that was already in place. Recruitment could start almost immediately, and the project avoided the rough start that often generates unnecessary costs and delays for the sponsor.
The role of a partner supporting a clinical trial used to be seen in fairly narrow, task-based terms: prepare the documents, file the application, manage communication, support monitoring. Today, especially on international and more complex studies, that role is far broader.
A good partner should help the sponsor see the project as a whole, not only through the lens of formal requirements but also through the lens of feasibility. Do the chosen countries fit the timeline? Do the sites have a realistic chance of starting? Is the documentation tailored closely enough to each country? Are the operational risks understood before the study begins? Are vendors, sites, and the sponsor all working to the same schedule?
For the whole thing to run smoothly, it pays to begin with meticulous project mapping: what has to happen before submission, which elements can run in parallel, which decisions are critical to the timeline, where local differences are likely to surface, and which sites need closer support. The approach is not glamorous, but in clinical trials, it is genuinely valuable because it reduces surprises.
Poland has a strong case as a country for conducting clinical trials: experienced investigators, large sites, a broad patient population, and growing awareness of the role trials play in the healthcare system. Interest in more specialized projects is rising across oncology, rare diseases, advanced therapies, and diagnostics.
At the same time, that potential has to be translated into well-prepared projects. Sponsors expect more than patient recruitment; they expect predictability, high-quality data, and a smooth start. For sites, that means excellent internal organization, clear procedures, and a readiness to work with international teams. The partner’s job is to act as the link between the sponsor’s global strategy and locally established trial practice.
On projects involving Poland, it is often clear that good communication with a site, handled very early, can sharply improve a study’s predictability. Sometimes it is enough to settle the details of the patient pathway, the availability of a particular diagnostic, the administrative requirements, or realistic contracting dates in advance to avoid delays later in the project.
In the era of ACT EU and CTIS, a study succeeds not simply by completing administrative steps but by integrating them strategically. In our view, the work should rest on five foundations.
In the ACT EU era, there is no room for improvisation. A fast study is not one that sprints; it is one in which the risks were removed before they could materialize. Regulation, clinical operations, documentation, vendors, sites, and patients are not separate stages. They are parts of a single process.
The more complex the study, the earlier that process has to be integrated. That is especially true of international projects, of trials that require specialized diagnostics, and of areas such as nuclear medicine, where the organization of the work has a direct bearing on whether the protocol can be carried out at all.In practice, a fast study is not one run under pressure. It is one that was well prepared. And it is precisely here that operational and regulatory experience becomes one of the decisive ingredients of a project’s success.
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