OCT has received study approval from the Russian Ministry of Health to conduct a pediatric study in infants. newThe study will be performed in 6 sites in Russia. OCT targets to enroll 110 infants with colitis into the study. Key opinion leaders are involved in the study. The investigators have more than 15 years of experience in pediatric clinical trials. The trial is placed in the biggest pediatric institutions in Russia. The study will be performed in institutions that provide a child-friendly atmosphere with a pediatric infrastructure and personnel.
OCT Project Manager, MD, who is a pediatrician by education, and Russian investigators took part in Protocol adaptation to meet regulatory requirements and enrollment targets. The following changes were implemented:
It is well known that current legislation all over the world is forcing pharmaceutical companies to conduct pediatric studies as an integral part of the drug development because there are obvious anatomical features that differentiate children from adults. Today there is an increasing number of sponsors that undertake pediatric studies. That is why it is important for pharmaceutical companies to have reliable partner to conduct their pediatric trials who would assist to overcome enrollment issues and who would address the ethical, scientific, and regulatory issues in pediatric research.
OCT has good experience in pediatric studies in Russia and Central and Eastern Europe. OCT successfully utilizes its network of investigators experienced in pediatric clinical trials representing all pediatric sub-specialties.
Russia is home to the first in the world school providing higher medical education with a specialization in Pediatrics.
OCT team has several pediatricians, who share their experience with clinical team.
OCT have a huge database of investigational sites and key opinion leaders in CEE countries where we run pediatric clinical trials. We have experience in evaluation of sites and their appropriateness for pediatric clinical trials. We perform pediatric trainings to the team assigned to the trial.