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Federal Almazov Heart, Blood and Endocrinology Centre of Federation Agency on High Medical Technologies Experience in Clinical Trials conduction :
More then 120 international multicentral clinical trials organized since 2000
Successful auditioning by FDA in 2004
Experience in organization of all stages of clinical trials (1-4)
Main trends: cardiology, endocrinology, hematology, living cell technologies, reumatology.
Currently, in Almazov Federal Center are conducted clinical trials sponsored by more, then 20 pharmaceutical companies, medical equipment manufacturers and contract clinical trials organizations. The main reasons for the customers to choose Federal Almazov Center are the high professional level of its researchers - many of them have experience of participation in Internat ...ional Multicenteral clinical studies (active participation since 1998) and the opportunity to involve in the treatment of patients the high medical technologies in the Center's inpatient (for up to 480 patients) and outpatient (up to 360 patients a day) departments.
The Almazov Center procedure of Clinical trial conduction approval
To approve the conduction of phase I-IV clinical trial (further on - Trial) in Almazov Federal Center the customer must refer to the Clinical Trials Department with the following documents:
1.The project of agreement between the Center and the Co missioning organization must include information about:
duration and extent of clinical trial conducted;
overall funding of the clinical trial and/or the funding for each patient included in the trial;
the dates of payment related to the date of signing the acceptance certificate;
the form of report;
insurance policy in aspects, concerning the state of health of patients that participate in the trial;
the terms of general liability insurance for the conductors of the study
2.Clinical study Protocol.
After the approving of the contract for clinical trial conduction the document is signed by the Director of the Center, professor akhto, corresponding member of the Russian Academy for Medical Sciences. According to the procedure, one hard copy of the contract remains in the Department of Clinical Trials.
The procedure for ethical expertise
Standart operating procedures
Contact us
Regulation on the functioning of Ethical Commitee
The Members of Ethical Commitee
Schedule of Ethical committee meetings for 2008 Read more
More then 120 international multicentral clinical trials organized since 2000
Successful auditioning by FDA in 2004
Experience in organization of all stages of clinical trials (1-4)
Main trends: cardiology, endocrinology, hematology, living cell technologies, reumatology.
Currently, in Almazov Federal Center are conducted clinical trials sponsored by more, then 20 pharmaceutical companies, medical equipment manufacturers and contract clinical trials organizations. The main reasons for the customers to choose Federal Almazov Center are the high professional level of its researchers - many of them have experience of participation in Internat ...ional Multicenteral clinical studies (active participation since 1998) and the opportunity to involve in the treatment of patients the high medical technologies in the Center's inpatient (for up to 480 patients) and outpatient (up to 360 patients a day) departments.
The Almazov Center procedure of Clinical trial conduction approval
To approve the conduction of phase I-IV clinical trial (further on - Trial) in Almazov Federal Center the customer must refer to the Clinical Trials Department with the following documents:
1.The project of agreement between the Center and the Co missioning organization must include information about:
duration and extent of clinical trial conducted;
overall funding of the clinical trial and/or the funding for each patient included in the trial;
the dates of payment related to the date of signing the acceptance certificate;
the form of report;
insurance policy in aspects, concerning the state of health of patients that participate in the trial;
the terms of general liability insurance for the conductors of the study
2.Clinical study Protocol.
After the approving of the contract for clinical trial conduction the document is signed by the Director of the Center, professor akhto, corresponding member of the Russian Academy for Medical Sciences. According to the procedure, one hard copy of the contract remains in the Department of Clinical Trials.
The procedure for ethical expertise
Standart operating procedures
Contact us
Regulation on the functioning of Ethical Commitee
The Members of Ethical Commitee
Schedule of Ethical committee meetings for 2008 Read more
Category
- Organizer