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Drug Clinical Study and Pharmaceutical expertise are the basic parts of drug registration in Russia

Drug Clinical Study and Pharmaceutical expertise are the basic parts of drug registration

Why are Drug Clinical Studies required?

After drug development it is important to understand how we can use the drug for the purposes declared by physicians.
The Results of the Study are essential and necessary. A Pre-Clinical Study is the first stage for a drug.

So, if a Pre-Clinical Study is successfully completed, the next Stage is Drug clinical study. There are pilot, randomized, controlled and uncontrolled studies, parallel studies and many other types of mini-studies. Therefore, Clinical Studies are not fast, and pharmaceutical examination can take a long time.
In Drug Clinical Studies researchers examine the drug and the effects that the drug may have on human health.

The aim of this study is to evaluate the safety and efficiency of the newly developed medicine. It is necessary to find out and to prove clinical pharmacological drug attributes and pharmacodynamic properties.

Drug absorption, distribution, metabolism, excretion and interactions are assessed by experts.
A permission for the conduct of a clinical study is given by the Institutional Review Board (IRB)/ Independent Ethics Committee(IEC).

So, a healthy volunteer or patient signs the informed consent form. All required documents are prepared. After detailed examination of the informed consent documents the voluntary informed consent form is written. Following this document the person becomes the research subject and is included in the Clinical Study protocol.

In the Clinical Study protocol the investigation process is clearly described.

The Risks and Benefits are balanced in Human Subject Research and this balance is assessed by experts. The study protocol and other study documentation is examined and approved1.
And finally, the decision is made.

IRB/IEC give you a permission for the conduct of a Clinical Study and you can begin the Clinical study.

“Regapharm” will help you to conduct Clinical Studies successfully!

“Regapharm” conducts the Clinical Study in accordance with the ICH GCP, the Russian Federal law, with the requirements of the Ministry of Health and Social Development of the Russian Federation and the Federal State Institution  the “Scientific Center for the Expertise on Medical Products for the Ministry of Health and Social Development of the Russian Federation”.

  1. Quick and easy! We prepare all medical documents for the Clinical Study.  And we accelerate the preparation of the regulatory submission package for authorization to start clinical research.
  2. We help you to obtain permission for the conduct of a Clinical Study. Our experts will obtain all the documents for the conduct of a Clinical Study in Russia.
  3. We will help you in your time of need! We conduct a Clinical Study, perform statistical analysis and write the final Clinical Study report.
  4. When the study is completed, we perform an expert drug quality examination to find any potential risks versus expected benefits of drug use.
  5. Complete the Dossier in accordance with FL-61 and submit the application to the MoH in order to obtain authority. After the expert drug quality examination we will be ready to obtain Marketing Authorization.
  6. We will reach regulatory approval for Drug Authorization (Ministry of Health of the Russian Federation). The drug will be included in the State Register of Medicinal Remedies and Marketing Authorization will be obtained.

Who decides

The Sponsor (company) initiates a Clinical Study. He is responsible for the management, control and, possible, finance.
Therefore, the Investigator (individual or group) is responsible for conducting the clinical study.
In general, the Sponsors are Drug developers - pharmaceutical companies. Of course, the Investigator may be Sponsor on his own. So who takes full responsibility for this activity if the pharmaceutical expertise and the investigation are initiated by him? The answer: He does

The Clinical Study is conducted in accordance with special requirements2.
The potential risks versus the expected benefits to subject health and also for society are evaluated at the beginning of the study.
Protecting the rights and safety of subjects in the Clinical Study is the main purpose. Protection from health injuries is very important. This significant concept dominates science and public interest.

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