Ensuring compliance with regulatory requirements at local, national and EU level is a key element in the design of clinical trials in every EU country. We will write about upcoming changes in regulations in 2020 in this article. While logistics and planning constitute the majority of the work involved in clinical trial design, a critical […]

In one of the latest FDA reports on global participation in clinical trials in the period 2015-16, Poland is the fourth-largest centre for clinical trials worldwide with an estimated recruitment of >5000 trial participants, amounting to almost 4% of the global recruitment (Figure 1).[1]  In addition, with regards to the EU, Poland ranks a close […]

In this chapter, we will elaborate on the factors that need to be focussed on while conducting a feasibility analysis. One of the key processes that occurs in parallel to designing a clinical study is evaluating the feasibility of conducting the study in a particular country of interest. However, since the smooth running of a […]

A study which is poorly designed will yield false results at an enormous expense of time and money. The main aim of clinical studies is to as closely represent the real-world outcomes as possible and the design of the study has a large bearing on whether to accept or reject the null hypothesis. A study […]

In recent years, Poland has become an attractive location in the EU for conducting clinical trials, owing to the availability of state-of-art infrastructure, medically qualified personnel, and legislative policies fostering healthcare research. Moreover, Poland is also considered to be one of the fast-growing markets for medicines and healthcare (PWC: From Vision to decision: Pharma 2020). In […]