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9Clinical trial - a systematic study of the drug on humans (in patients or healthy volunteers) in order to detect or confirm its effects on the body and / or identify any adverse reactions to an investigational drug and / or study the absorption, distribution, metabolism and excretion to establish its efficacy and safety.

Clinical studies conducted after the experimental trials, and include a Phase I (the definition of security and doses), II phase (performance evaluation and determination of side effects), III phase (compare the effectiveness of monitoring and long-term use), as well as post-marketing studies.

In evaluating the data on new drugs primarily addresses two key questions:

  • Do the results of controlled clinical trials enough evidence for the efficacy of the drug;
  • Is the drug safe in terms of benefit / risk ratio.

It is necessary to prove not only safety and efficacy of new drugs, but also its effectiveness, suitability, productivity, that is, whether the drug works, whether the robust results are acceptable if the side effects, whether the drug demand, which of the dosage, modes of reception, formulations work best in which situations, for which categories of patients the drug is contraindicated or most shows, etc. In short, the therapeutic benefit of the drug is determined in general.

Want to organize clinical trial of your product or sponsor’s product ?

We will provide full support to the clinical / post-marketing trials and their conduct as a contract research organization.

  • assessment of the feasibility study
  • selection of clinical sites
  • risk analysis and contingency planning
  • translation and documentation of clinical trials, postmarketing clinical trials, research programs (including patient information and informed consent form)
  • an application for conducting clinical trials and obtaining regulatory approval
  • training of investigators
  • organization and conducting meetings for investigators
  • study monitoring
  • system of import/export, storage, distribution, return and destruction of clinical trial materials
  • management of the clinical trial sites
  • preparation for auditing the quality of clinical research by the authorized bodies
  • project Management
  • monitoring and reporting of safety issues

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