"One of the most common questions that we are asked by the sponsors is about clinical trial standards and applicability of ICH-GCP. They get relieved when we tell them that in all local jurisdictions the national clinical trial standards are a direct translation of ICH-GCP.
Their next question is often about whether the clinical data generated in CEE is accepted by the FDA and the EMA. The answer is a resounding “yes”. At least 70% of large scale international pivotal trials engage CEE sites and often have a bulk of patients recruited there."
"Based on the data from clinicaltrials.gov and clinicaltrialsregister.eu the most prolific countries in clinical research are Poland, Hungary and Russia. I am happy to say that we are successfully operating in all of them."
"Overall, timelines are very competitive with WE and are much more palatable that many other regions that we compete with."
Tuesday 1 December marked World AIDS Day 2020. Although throughout this year our focus has been on the coronavirus pandemic, World AIDS Day is an opportunity to reflect on another pandemic where a virus passed from animals to humans with devastating consequences. To date 77 million people worldwide have been infected with HIV. In spite of innovative new treatments 35 million people have died from the virus.
If you missed the live webinar “Where in the world should I locate my pivotal clinical trial?” you can now watch the recording by clicking here. The webinar hosted by the Society of Physician Entrepreneurs (SoPE) and Workforce Genetics features Cromos Pharma's CEO Vlad Bogin, M.D, FACP.