Volunteer
To be a volunteer in clinical trials means to make invaluable contribution to science and drug development
Experienced medical staff specializing in clinical trials
What is a clinical trial?
Clinical trials are conducted to evaluate the efficacy and safety of a drug or method on treatment on humans. Before the start of phase I studies, the effect of the drug is studied in detail in laboratories and preclinical trials.
Clinical trials are conducted under the strict supervision of the Ministry of Health and the local ethics committee.
Usually, volunteers participate in bioequivalence and Phase I studies.
At our Site research is conducted by qualified medical personnel.
What is a bioequivalence study?
In determining bioequivalence, for example, between two products such as a commercially available Brand product and a potential to-be-marketed Generic product, pharmacokinetic to volunteer subjects, generally healthy individuals but occasionally in patients. The study confirms that drugs are metabolized in the human body the same way.
What is phase I studies?
Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t be known for sure.
What about safety?
- Clinical studies are regulated by Ministry of Health. Each study is reviewed, approved, and watched over by an independent panel of qualified doctors, researchers, and members of the community called “Local ethic committee.” This committee makes sure that your rights, safety, and welfare are protected and that the study itself is being done for honest and ethical reasons. It also makes sure that the health risks involved are reasonable compared to the possible benefits.
- The study doctor will give you an introductory talk and answer any questions you may have before you sign your informed consent to participate in the study. You are given enough time to make a decision. Consent to participate can be withdrawn at any time, regardless of the stage of the study.
- Life and health of the participant during the study is insured.
Who can involve in research ?
A healthy volunteer is a person who has no significant health problems for the study.
General requirements for volunteers:
- Men and/or women (depending on the study)
- Age: 18 – 45
- No chronic diseases that can affect the results of the study
- No significant allergic reactions
- No alcohol and/or drug addiction
- Negative pregnancy test (for women)
What a volunteer gets?
- Diagnostic tests and laboratory analysis are performed free of charge on modern equipment by international standards
- You get compensation of minimum 12,000 rubles for participation
- Three meals a day will be provided during hospitalization
- You make an invaluable contribution to science and drug development
BENEFITS
All staff have more than 3 years of experience in clinical trials
In our site staff training annually to improve the quality of work
The site complies with good clinical practice (GCP) and Russian legistation
An individual approach to each volunteer, we quickly respond and answer questions
Before you sign informed concern, you have an introductory interview with a co-investigator
Contacts
If you have any questions, write to info@x7clinical.com
Address
194156, Russia, St. Petersburg,
Engelsa Av., 27T
Every day from 10:00 to 18:00
About Us
X7 Clinical Research Center conducts clinical trials of Bioequivalence and Phase I. Clinical Center strives to preform all research at the highest quality level while maintaining the safety and security of all trial subjects
Полина Хлябова присоединилась к команде X7 Clinical Research в 2019 году в должности Директора по обеспечению качества. Занимается клиническими исследованиями с 2010 года. Имеет более 4-х лет опыта обеспечения системы управления качеством в исследовательских центрах и контрактно-исследовательских организациях. Участвовала более, чем в 34 исследованиях в качестве главного исследователя, и в 90 исследованиях в качестве со-исследователя. В 2008 году закончила лечебный факультет СПбГМА им. И.И. Мечникова, врач терапевт, клинический фармаколог, аллерголог иммунолог. C 2015 имеет диплом по “Организации здравоохранения и общественного здоровья”.
Кристина Берестян присоединилась к команде X7 Clinical Research в 2019 году в должности Специалист по вводу данных, затем как Специалист по набору субъектов исследования. За время работы в X7 Clinical Research приняла участие в клинических исследованиях III фазы и исследованиях биоэквивалентности в роли Координатора.
Ольга Васютичева присоединилась к команде X7 Research в 2020 году в роли Заведующего аптекой. Работала в ООО «Фирма Медмаркет» на должности Фармацевт, ЗАО «Империя – Фарма» на должности Заместитель начальника отдела сертификации фармацевтического склада, в ООО «ПрофСоюз» на должности Заведующий фармацевтическим складом, в ООО «Рабиус» на должности Провизор/Заместитель заведующей аптеки.
Вадим Степанов присоединился к команде X7 Clinical Research в 2019 году в должности Врача-терапевта. Участвовал в клинических исследованиях различных нозологий III фазы, биоэквивалентности, в роли Со-исследователя. Работал в ОАО «Системный оператор ЕЭС России» на позиции Врач-терапевт.