Development of the Phase I-III
Research Program

Getting a permit for
conducting a clinical trial

Obtaining of import authorization
for unregistered medicinal product

Selection of clinical base for research

Organization of patient insurance,
participating in the study

Conclusion of contracts with performers,
passage of Local Ethical Expertise

Monitoring of the research
at all stages of its conduct

Statistical analysis,
preparation of the Clinical Research Report

Clinical tests are an indispensable stage in the process of creating a new drug for the treatment of various diseases. In addition, they can also be used to expand the scope of the drug and use it to get rid of more pathologies. The clinical phase follows the preclinical phase, during which the effectiveness of the use of the drug (medicine) is evaluated by scientific methods

 

In contrast to preclinical tests, clinical tests allow us to gather a sufficient amount of information on how the components of the drug created will act on the human body (rather than the laboratory animal).

 

General requirements for clinical tests in a clinical way

A clinical test involves studying the work of a drug by using it to treat a person. To do this, volunteers with some kind of pathology or healthy people are used. In the course of the study, the safety of the use of the drug and its effectiveness are established to get rid of a particular ailment.

In addition, data are collected on the additional properties of medicine:

 

In addition, data are collected on the additional properties of medicine:
 

  • pharmacological;
  • pharmacological;
  • Clinical.

Specialists conduct a final study of the absorption of the drug, its distribution through the internal systems of the body and removal from the organs.
 

Any organization or company can order the conduct of clinical tests. Their executor is a specialized clinic or center that has the right specialists, equipment, experience, permits and licenses.

 

The testing of the drug in humans is carried out in strict accordance with the GSP rules and the current regulatory documents of the Russian Federation and international organizations. Clinical tests are preceded by an assessment of the possible risk to the volunteer and the benefits that the creation of a new drug will bring.

benefits that the creation of a new drug will bring. Before carrying out the study, a protocol is drawn up, on the basis of which a decision is made about the possibility of starting work.

 

Phases of clinical tests

Clinical tests are conducted in several phases:


1. Phase I, during which the medicine is first tested on a person. From the fact how well this stage of work will be planned and carried out, the possibility of releasing the finished product on the market depends.

& Tests of the first phase are carried out after studying the developed medicine by scientific methods. The drug is tested on healthy volunteers or people with diseases for which medicine has been developed. During the first phase, the experimental subjects are given single doses of the drug with a gradual increase in its quantity in order to determine the safety of the drug components for the organism and to study the pharmacological and pharmacokinetic properties. The duration of this stage is up to 2 months.

 

2. Phase II, during which an assessment is made of the effect of the drug on the human body, suffering from a particular pathology.

В процессе исследования собираются данные, подтверждающие краткосрочную безопасность лекарства для человека, а также необходимые дозы его употребления. Кроме того, результаты этой фазы должны доказать эффективность использования ЛП для лечения. 
 

3.During the test, data are collected that confirm the short-term safety of the drug for a person, as well as the necessary doses of its use. In addition, the results of this phase should prove the effectiveness of the use of medicine for treatment

 

The duration of studies within the Phase II can range from 2 months to 2 years. Studies are conducted on hundreds of people with the use of control groups.

 

4. Phase III, during which experts study the effectiveness of the drug and its safety in the amount necessary for the treatment of pathologies, and compare the results with the characteristics of other drugs. It is the results of this phase that enable the medicine developer to apply for the registration of a new medicine. Duration of studies - up to 6 months.
 

During this stage of the tests, the drug is tested on a large (up to 1000 people) number of people, including patients at risk. The third phase allows to identify possible side effects and peculiarities of the action of the drug components on patients with abnormalities in the work of internal organs and systems. There is also a IV phase, which is carried out after the registration of the drug to assess its use and revision of methods of use .

Where to order

Are services required to conduct phase I-III clinical tests? Please contact the Center for Clinical Research "Promedika". Contact our specialists you can use the feedback form on the website or by phone.

For the primary analysis (scheme), cost and timing of registration of funds (LS),
Medical products (MI) and dietary supplements according to the rules of the Russian Federation
and the United Arab Emirates the manufacturer must provide the following data:

Medicine

1. Instructions for use


2. Detailed composition


3. Certificate copyGMP


4. Data on pre-clinical and clinical trials


5. The status of product registration in the country of production



Medical product

1. Description of the medical device


2. Copy of ISO certificate, CE certificate (or other similar documents)


3. Data on pre-clinical and clinical trials


4. The status of product registration in the country of production

 



BAA

1.Instructions for use


2. Full composition with percentage of components


3. A copy of the GMP certificate and / or ISO and / or HACCP


4. Data on pre-clinical and clinical trials


5. A copy of the safety certificate for product

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