"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."
Cromos Pharma is delighted to be taking part in the upcoming DIA Europe conference (15 – 19 March 2021) and BIO-Europe Spring (22-25 March 2021).
February 11th is International Women and Girls in Science Day. A joint UNESCO and UN-Women initiative, it aims to promote the role of #WomenInScience and to challenge some of the barriers to girls pursuing a career in science.
Are you a sponsor seeking to conduct clinical trials in the European Union but do not have a registered office in the European Economic Area? If so, in order to comply with the European Union Clinical Trial Directive, you are required to work with a Legal Representative registered in an EEA country.
Each 4th February, #WorldCancerDay aims to raise awareness of the global personal, social and economic burden of cancer. World Cancer Day was established in Paris at the first World Cancer Summit in 2000.
As 2021 begins, many countries are grappling with a renewed surge of COVID-19 infections necessitating further public health restrictions putting more pressure on health systems, societies and global economies. The task of rolling out approved vaccines is increasingly urgent. Almost 16 million doses of COVID-19 vaccines have been administered to date in 37 countries worldwide according to data compiled by Bloomberg ( updated 7 Jan 2021).
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.