| |
2010/8/13
Clinical Trials in Russia. 2nd Quarter 2010  2010/5/17
Clinical Trials in Russia. 1st Quarter 2010 2010/2/24
Clinical Trials in Russia. Year 2009 2009/12/15
SynRG becomes the first Russian member of EF GCP 2009/11/28
GCP Training in Kazakhstan
|
|
Synergy's liability insurance is $1,000,000 |
January, 2007
Synergy Research Group is the first Russian CRO that has voluntarily insured its professional services in clinical research with an impressive total coverage of $1,000,000, and a one-time limit of $500,000. The coverage has been active since January 01, 2007.
The issue of business insurance in Russia is rather complicated. Protecting the patient rights is one of the basic principles of clinical research, and insurance is one of the real mechanisms of insuring patient's safety. Insurance issues are strictly regulated by international and Russian laws, one of which is the Russian Federal Law "On Pharmaceuticals" from June 22, 1998.
There are two groups of risks involved in the clinical research - the risks related to the drug, and the risks related to research mistakes. The law does not mention kinds of insurance and contract conditions; it only defines the need of obtaining patients' health insurance and research personnel liability insurance. Because the law does not specify who exactly the research personnel is, the common practice used to include only liability insurance for the sponsor company, the pharmaceutical company that produces the study drug, and the research center personnel.
Taking into account the role of the Contract Research Organization, Synergy Research Group has become the first CRO in Russia that voluntarily insured its business practice for $1,000,000. By doing so, Synergy has demonstrated a high level of responsibility, adherence to the ICH-GCP ethical principles, and proved its gravity and serious intensions in the Russian market of clinical research.
|
|
 |
|
