Clinical trials in Russia

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We conduct phase I-IV clinical trials, including:

We conduct phase I-IV clinical trials, including:

  • Bioequivalence Study (including in vitro study in the framework of the procedure, biowaiver).
  • Clinical studies of potent drugs (narcotic, psychotropic substances).
  • Clinical studies of biological drugs.
  • Clinical studies evaluating the efficacy, safety, and pharmacokinetics of drugs in various nosologies (including orphan diseases) and in different patient populations (including children).
  • Pharmacoeconomical and epidemiological studies.
  • post-Registration studies of effectiveness and safety, prospective and retrospective non-interventional studies.

 


For all types of clinical trials, we offer the following services (including, but not limited to):

1. Preparation for a clinical trial:

  • project Planning: development of the study design and statistical analysis plan, selection of clinical databases;
  • development of documentation (medical writing) for clinical research: Protocol, researcher's Brochure, patient's Information sheet with informed consent form, literature reviews, etc.;
  • Technical and economic evaluation of a clinical trial;
  • translation of documentation with quality control of translation;
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  • Submission of documents to MOH with the aim of obtaining permission to conduct clinical research and support of the project before obtaining permission from the health Ministry (including responses to requests of the regulator).

2. Organization and provision of a clinical trial:

  • project Management;
  • Coordination and control of import of the test drug and / or comparison drug (including obtaining permission from the Ministry of health of the Russian Federation for import, preparation of a letter of justification of the required amount of the drug for the purposes of the study).
  • Conclusion of contracts with research centers, researchers and third parties (analytical centers, Central laboratories, logistics companies);
  • preparing researchers for a clinical trial, training the research team (including GCP training);
  • it support for clinical research - development of electronic IRC with accompanying documentation (EIRC layout, validation plan, annotated IRC, UAT report), database management;
  • Organization of transportation of biological samples, medicines and consumables (including ensuring continuous monitoring of the required temperature regime);< / li>
  • monitoring of a clinical trial;
  • Ensuring that the research is carried out in accordance with the requirements of quality standards (local and international regulatory requirements (including the EAEU), the company's SOP/customer's SOP);
  • ensuring the safety of clinical trial documentation, archiving research documents after completion of the study;
  • Biostatistics - collection and statistical processing of data obtained during the research (intermediate data analysis, preparation of a statistical report);
  • Preparation of the final report on the results of a clinical trial;
  • Pharmacovigilance (including collection of safety data-adverse events and serious adverse events, informing regulatory authorities), except for the 24/7 call center.
You need to know
Read useful information on the legal framework of the Russian Federation and our activities in the field of scientific and practical conferences and congresses.
Useful information
Useful information
Legal basis of clinical trials of drugs in the Russian Federation.
Our event
Our event
Plan of scientific and practical conferences and congresses organized by Medical Development Agency in 2019-2020.
Our team
Medical Development Agency specialists are not just experienced managers who have a solid background of knowledge, skills and successfully implemented projects. It is also a friendly, cohesive team that ensures a high level of efficiency of our work and the competitiveness of the company in the market.
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