How long does the start-up phase of a clinical trial last in Poland? Realistic timelines and factors affecting the project start.
The start-up phase of a clinical trial is one of the most important stages before patient recruitment begins. It involves all actions leading from the finalization of the study documentation to obtaining all regulatory approvals and activating research centers. Sponsors planning a project in Poland often ask how long this process realistically takes and when it is possible to start the first patient visits.
In practice, the duration of the start-up phase in Poland typically ranges from 3 to 6 months, though for more complex projects, it may extend to around 7-9 months. The length of this phase depends on many factors, including the preparation of documentation, the number of countries involved in the study, the experience of the centers, and the efficiency of managing the regulatory process.
A key element of the start-up is obtaining clinical trial authorization through the CTIS system in accordance with EU regulation 536/2014. The procedure involves a parallel assessment by regulatory bodies and the ethics committee. The standard time for formal and substantive review is several weeks; however, in practice, the process is often delayed due to the time needed to prepare responses to regulator inquiries (RFI). Therefore, the quality of the application directly impacts the overall study start time.
At the same time, operational activities related to selecting and contracting research centers are underway. Negotiating contracts, agreeing on budgets, completing investigator documentation, and preparing centers for the study are among the most common factors affecting the start-up timeline. In Poland, an important element is also the process of concluding tripartite agreements and negotiations with medical units, which may vary in execution time depending on the center.
The length of the start-up phase is also influenced by the preparation of study systems such as eCRF, randomization platforms, training research teams, and product logistics. Projects where regulatory and operational activities are conducted in parallel generally achieve a much shorter timeline for the activation of the first site.
Experience shows that the greatest delays arise not from regulatory requirements themselves, but from a lack of coordination between clinical operations and data management teams. This is why more and more sponsors are choosing to involve a CRO early in the start-up planning phase, allowing them to optimize the schedule and minimize the risk of multiple document revisions.
The Biostat team supports sponsors in the comprehensive management of the clinical trial start-up phase — from preparing CTIS documentation, through communication with regulators and the ethics committee, to the activation of research centers. Properly planned start-up can significantly shorten the time to the first patient in (FPI) and increase the predictability of the entire project.
If you plan to start a clinical trial in Poland or abroad and want to realistically estimate the start-up timeline, consulting with an experienced CRO partner will allow you to identify potential risks early on and expedite the trial's start.
