Clinical trials in Ukraine
Smooth Drug Development offers clinical trial services in Ukraine.
Ukraine is a gem country for clinical trials conduct. Ukraine being an emerging market, provides uncomparable advantages to clinical trials Sponsors. These include 3x higher recruitment rates than US and EU, reduced clinical trial expenditures and high quality data generated by Ukrainian sites.
Our capabilities include full service clinical trials:
Phase I
In terms of phase I studies investigators examine absorption, distribution, and excretion of medical products. At this phase researchers evaluates safety and appropriate dosage of the studied drug. Phase I may last from several weeks to more than one year.
Phase II
This phase takes the study to a new level and involves significant population of several hundred patients, selected according to strict criteria. Their medical condition must fit the indications of studied medicine. At this stage investigator keep assessing safety and effectivity of the drug.
Phase III
This is the last developmental phase of drug examination. At this phase researchers conduct a randomized trial in a vast population of patients with various degrees of disease severity. The major objective of this phase is to test the assumptions of previous phases and achieve statistical power, necessary for proving safety and efficacy of the drug.
Phase IV
This phase is conducted after the registration of the medical product and aims at broader examination of the drug. Investigators examine efficacy of the drugs in combination with other medicines, foods, and therapeutic plans.
Bioequivalence studies
Examination of bioequivalence usually addresses comparability of one drug to another, usually a generic drug to the original medicine. In terms of this study, investigator assess level and speed of absorption, concentration of the drug in blood at specific points, distribution, and excretion of medicine.
Smooth clinical trial is about adherence to the highest standards
Smooth facilitates strict and effective quality control over the trials in Ukraine. Smooth Drug Development obtained multiple ISO certification, which include certificates in "Quality Management Systems – Requirements" and "Societal security – Business continuity management systems – Requirements". In 2018, Smooth plans to receive ISO 27001 certificate in information security.
Smooth applies high quality standards for local trials in Ukraine as well as to international trials, which help to provide homogenous data of good quality. Our quality management approach and business continuity systems allow to conduct international studies in post-Soviet area disregard political and economic situation.
Smooth clinical trials are rooted in local advantages
Smooth Drug Development has a flexible business structure, which allows to employ maximum advantages of Ukrainian clinical trials market. Good knowledge of local legislation and specificities enables Smooth Drug Development to deliver maximum benefits to each particular trial, which saves time and consequently provides our Sponsors advantages on the market.