The conduct of clinical trials in Ukraine
In this article we will talk about what KIO (or CRO) than they booolshaaayaaa and why Ukraine is an interesting place for clinical trials for pharmaceutical companies from around the world.
Any manufacturer of medicines sooner or later meets the need to conduct clinical studies. This step is a necessary step in the development of almost all medicines. Before it was developed standards and regulations for clinical trials they can be carried out by the pharmaceutical companies. But after there were some tragedies that are caused are not fully understood properties of drugs, regulators mnogikh countries consider the introduction of a tough regulatory rules for clinical trials.
so, since 1995, clinical studies of drugs quite strictly regulated by legislative norms. In addition, there are very significant demands on data quality, record cover documentlibrary,. These requirements are intended to clinical trials as safe as possible in relation to patients, was implemented ethical standards, the results obtained were accurate and processed correctly by statistical methods.
All of these requirements led to the fact that clinical trials have become bulky and voluminous projects that require high qualification of all involved professionals and coordinated work between them in the process of implementation of the project. Over time, there is a contract research organization (CRO or CRO), which deal only with execution of clinical research. They accumulate experience and knowledge and are able to competently carry out projects directly for farmproizvoditelej.
KIO currently able to perform all the required load for the planning and conduct of clinical trials. These companies performed a variety of complex procedures. Experts KIO and create the proper design of clinical studies, form all the necessary documentation to attract researchers, provide compliance reporting, monitor the quality of data collected, perform trainings, do statistical processing of the results. They also provide assessment and coordinate the work of subcontractors who perform certain types of work.
Thus, the establishment of the principles of clinical research naturally led to the creation of specialized companies that take on a specific load, removing some of the problems in this direction with the big pharmaceutical companies. This trend first appeared in the West, and then came to Ukraine.
In the opinion of many experts in Ukraine has a number of advantages. First, the country harmonized legislation and because of this, the scientists familiar with the rules and standards of conducting clinical research in practice. Also, our doctors are interested in the quality performance of clinical trials as it allows them to get a solid raise. This motivates to deliver quality work. If you compare the success and speed of enrollment of patients in our scientists, it appears that they can be leaders compared to researchers from other countries. The company's experience, Pharmacy confirms this.
Hope that Ukraine will be more prominent as a country with high potential for clinical trials to customers from all over the world.
Translated by "Yandex.Translate": translate.yandex.ru.