H-Clinic — clinical base for clinical research
Permission documents
Medical license
No. ЛО-77-01-014544 of July 11, 2017,
No. ЛО-77-01-015029 of October 18, 2017,
No. ЛО-77-01-016391 of July 18, 2018.
No. ЛО-77-01-014544 of July 11, 2017,
No. ЛО-77-01-015029 of October 18, 2017,
No. ЛО-77-01-016391 of July 18, 2018.
Farmacy license
No. ЛО-77-02-008551 dd. May 18, 2017.
No. ЛО-77-02-008551 dd. May 18, 2017.
Certificate of accreditation for the right to conduct clinical trials of drugs for medical use No. 1549 of November 9, 2017, valid until November 9, 2022:
• selection of the optimal dosages of the drug and the course of treatment for patients with a particular disease, the optimal doses and vaccination schemes for immunobiological drugs on healthy volunteers;
• establishing the safety of the drug and its efficacy for patients with a particular disease, the prophylactic efficacy of immunobiological medications on healthy volunteers;
• exploring the possibility of expanding indications for medical use and identifying previously unknown side effects of registered drugs.
• establishing the safety of the drug and its efficacy for patients with a particular disease, the prophylactic efficacy of immunobiological medications on healthy volunteers;
• exploring the possibility of expanding indications for medical use and identifying previously unknown side effects of registered drugs.
Material base
The clinic is situated in a separate part of the medical center "Overcoming" in Moscow, st. March 8th, 6A, bldn. 1, 4th floor.
For clinical trials, there was allocated a separate equipped room for storage of drugs, bio samples, documentation during and after the trial, including the archive.
For clinical trials, there was allocated a separate equipped room for storage of drugs, bio samples, documentation during and after the trial, including the archive.
Diagnostic equipment
Ultrasound Diagnostic System Logiq F6 (2017)
Apparatus for non-invasive determination of the degree of liver fibrosis and steatosis 502 TOUCH (2017)
Electrocardiograph SCHILLER CARDIOVIT AT-2 (2018)
A set of monitors of computerized wearable 1-2-3-day monitoring of ECG, blood pressure and heart beat rate КМкн-«Союз-ДМС» (2018)
Digital optical video colposcope KN-2200 (2017)
Laboratory
- The clinic uses the services of CMD Laboratory.
- The delivery of samples to the laboratory takes place 2 times a day
- The results of urgent tests are got within 1 business day
- The exchange of laboratory data is implemented via a secure communication channel with the MIS "InfoClinic".
- We have the ability to install laboratory equipment and conduct laboratory tests on the basis of the clinic
- We also work with the laboratories T-SPOT and INVITRO
Research team
Principal Investigator —
Veronika Kanestri, Doctor of Medicine
Veronika Kanestri, Doctor of Medicine
- Infectious disease doctor (certificate number 0277180210885 "Infectious diseases")
- Experience - 20 years
- Clinical research experience - 19 years
- 20 clinical studies
- Certificate of GCP №8291 of 06.02.2019
- infectious disease specialist
- GP specialist
- dermatovenerologist
- TB specialist
- neurologist
- cardiologist
2
Doctors of Medicine
5
PhD
in Medicine
in Medicine
- gynecologist
- gastroenterologist
- ultrasound specialist
- functional diagnostics
doctor - nursing staff
Specialists:
University Clinic
H-Clinic is the clinical base of the Department of Infectious Diseases with courses of epidemiology and phthisiology at the Medical Institute of the Peoples' Friendship University of Russia (RUDN). Based on H-Clinic, the "Infectious Diseases" students and postgraduates study and conduct research.
Medical records
ELECTRONIC AND/OR PAPER
(DEPENDS ON REQUIREMENTS)
Medical documentation is carried out in printed form and in the MIS "InfoClinic":
(DEPENDS ON REQUIREMENTS)
Medical documentation is carried out in printed form and in the MIS "InfoClinic":
- The database of MIS "InfoClinic" is stored on a secure server in the clinic.
- It is possible to have a separate block in the system with access only for the Principal Investigator.
- The system keeps track of who makes changes to the documentation and when.
PROTECTED COMMUNICATION CHANNELS, SEPARATE SERVER AND SPECIALLY EQUIPPED STORAGE
- Medical documentation is additionally maintained on paper and stored in a specially equipped room.
- The information from the laboratory is transmitted via secure communication channels and special mail.
Patient base
3 502
total patients
100%
100%
1 958
men
56%
56%
1 544
of women
44%
44%
1 249
HIV
388
Viral Hepatitis
239
Other infections
1 626
Other
Nosologies under Treatment, Observation and Research (ICD-10)Patient base
14 964
Total visits for the previous year
(d-t-d as of 05/24/2019)
(d-t-d as of 05/24/2019)
Patient contacts
The clinic has a direct contact with a wide range of patients with infectious diseases because:
- At the clinic, there is a community of loyal patients (H-Club) who conduct regular H-School patient school classes, lectures and meetings.
- The clinic works with NGOs: EVA, LA SKY, Boys Plus, Svetlana Izambaeva Foundation
- Specialists of the clinic have access to the closed patient forums and public groups in the social networks.
Direct contact with a wide but closed audience of patients with various infectious pathologies allows us to recruit participants for clinical trials quickly
Ability to conduct clinical research
PERMISSION
DOCUMENTS
DOCUMENTS
LOCAL ETHICAL
COMMITTEE
COMMITTEE
with representatives
of NGOs without fees
for their work
of NGOs without fees
for their work
MATERIAL
BASE
BASE
Premises
and equipment
and equipment
CLINIC UTILIZATION
RATE IS 65%
RATE IS 65%
At least 1/3 of the working time of the clinic's specialists is available for clinical trials
UNIQUE PATENTS
BASE AND ACCESS
TO PATIENT
COMMUNITIES
BASE AND ACCESS
TO PATIENT
COMMUNITIES
LABORATORY
CMD and the possibility
of placing on clinic
own base
of placing on clinic
own base
Thank you for your attention!