Innovation Pharmaceuticals Inc (IPIX)

[TheDane]

Excellent! “ Clinical Trials in Russia in Comparative Perspective”

https://www.linkedin.com/pulse/myths-misconceptions-clinical-trials-russia-julia-sardaryan/



It is hardly surprising, but clinical trials in Russia are no different from the European or American ones. The Russian national standard of clinical trials is a direct translation of ICH GCP and differs only in the spheres where the international standards intersect with particular regional regulations. Russia has been one of the most popular destinations for clinical trials outsourcing in the last couple of years. Russia attracted not only hundreds of western trials, but also many FDA inspections.


This chart is composed on the basis of the results of 113 FDA inspections in Russia, 138 FDA inspections in Germany, 110 FDA inspections in France, and 129 FDA inspections in Great Britain. This data is all that is available in the FDA databases. We excluded inspection parameters that didn’t find any issues in the countries from the chart. Unfortunately, it is complicated to make a comparison with the United States because FDA conducted thousands of inspections in its homeland and a fair comparison will demand a separate methodology.

As one can observe, the FDA inspections of Russian research sites demonstrate better results than those of the leading European countries. Russia has the highest number of sites with no deficiencies. Russian research sites demonstrate high adherence to the ethical standards, providing adequate ICFs and appropriate payments to volunteers. Clinical research in Russian sites also demonstrates high accuracy of records and strict adherence to investigational plans. Why? The answer is plainly simple: Russia is still considered a newbie in the clinical trials market, so the only way to obtain success is to try to be the best. Smooth Drug Development is also a part of this and that is why we are so concerned with ISO certifications of all major activities, constant training of our staff, development of e-solutions (e-PRO, CTMS, etc), and the advancement of clinical trials in Russia to the highest international standards.