LordSnooty21 Jan 2015 11:33
The Russians are well regulated, as I informed Scott yesterday via email. The clinical trials administration is very straightforward and based on official procedures developed by the Russian Ministry of Health. SynBio has to submit documentation to the MoH for permission to run the trials. The MoH and the Ethical Committee will provide the decision based on official procedures. SynBio as with any CRO has to provide periodic updates to the Trials Sponsor and the MoH, which includes, as a minimum, intermediate reports and final reports. The CRO and the clinical trials site have to, by law, inform the Sponsor promptly, (within 24 -48 hours) of any SAE, AE, and SUSAR.
The Sponsor has an ongoing control over any clinical trial and access to any information concerning the trial.
The Sponsor can also see any confidential patient records.
If successful, the clinical trials will be reported ASAP. If they are unsuccessful, the Sponsor may wish to hold the information back or suspend the trials to suit their business plans.