Clinical trials in Eastern Europe
Smooth Drug Development offers fast and cost-effective clinical trials solutions in Central Eastern Europe.
Smooth Drug Development adheres to the highest quality standards, which were forged and tested in more than 250 research projects of different scale in Eastern Europe and post-Soviet states. The Smooth team demonstrated its professionalism in dozens of bioequivalence studies as well as in many trials of high complexity. Smooth Drug Development has a very diverse clinical services portfolio. We are experienced in conduct of Phase I, II, III, and IV trials in all main indications. We held large and comprehensive international studies as well as local trials in Eastern European countries.
Smooth Drug Development participates in all types of studies in humans:
Phase I
The first phase research examines the tolerability and dosing in healthy volunteers. This first test in people usually involves small population.
Phase II
The second phase studies are dedicated to examination of how effective the medicine in treating the disease. The major aim of phase II trials is establishing the “proof of concept.” This phase is conducted in small populations of patients with certain medical conditions. Treatment of these patients is monitored in placebo-controlled studies. In the result of phase II studies, investigators advance the knowledge about safety of the product and evaluate the optimized dosage strength.
Phase III
This phase takes the trial to a larger investigative scale. Researchers examine the drug in large, randomized, placebo-controlled studies with significant patient population. Expansion of the population under the study allows to improve statistics and generate efficacy and safety data. The developmental clinical phases generate data, which is demanded for submission to the regulator. Although the regulations and requirement for receiving the regulatory approval differ across legislations, all states require to provide assessments of safety and security, which are obtained in studies of phases I-III.
Phase IV
This is the post-approval stage of medicine examination. Phase IV studies are dedicated to collection of supplementary information about safety, efficacy, or optimal use of the product.
Bioequivalence studies
Clinical trials of bioequivalence aim at establishing if two comparable drugs contain equal amount of the active ingredient(s) and demonstrate identical rise of blood-level concentrations in volunteers. The measurements of concentrations are conducted at specific intervals medication intake.
Noninferiority/equivalence studies
The primary goal of these research is to evaluate if new means of intervention demonstrate more efficacy than the conventional intervention methods.
Smooth means the highest quality
Smooth has several ISO certificates. Smooth Drug Development has been ISO certified for ISO 9001 "Quality Management Systems – Requirements" and ISO 22301 "Societal security – Business continuity management systems – Requirements".
Our adherence to the highest international quality standards enables Smooth Drug Development to be one of the leaders in Eastern European clinical trials market.
Smooth means flexible
One of the secrets of smooth clinical trials conduct is research-oriented business model of a CRO. Smooth adheres to this principle and always adopts its resources to the needs of particular studies. This peculiarity enables Smooth to offer efficient pathways for drug development, safe time, and employ all advantages of Eastern European clinical trials market for successful research.