Bionalytical laboratory EGR
EGR LLC is highly reliable USA partner offering high quality professional drug development services and comprehensive range of non-clinical and clinical development services to Pharmaceutical and Biotech Companies through wide network of highly accredited GLP and GCP-certified CROs located worldwide across Europe, USA and Asia (including Russia) operating to highest quality standards. EGR is also offering high quality clinically defined human specimens and a broad range of professional services focusing on sourcing, processing and analyses of biological samples and development of tissue-based products for research.
EGR is introducing the “one stop shop” services provided by SDD & BioEq to the USA and European Pharmaceutical and Biotech Companies aiming to achieve their regulatory and clinical milestones quickly and cost effectively by offering regulatory support for procurement of marketing authorization for pharmaceutical products in Russian Federation and a full range of CRO services including high quality comprehensive drug development services and comprehensive range of non-clinical and clinical development services in full compliance with ICH GCP principles while taking advantage of utilizing the benefits of cost savings and efficiencies of conducting clinical trials in Russia:
- Subject recruitment rates in Russia are high – much higher than in the USA and Western Europe especially for oncology trials
- Shorter timeframes for patient recruitment
- Shorter overall length of the study completion. In most cases time costs more than money
- Russian CRAs are trained in GCP and many are also members of International professional organizations such as DIA and ACRP
- Availability of patients with rare diseases and treatment-naive patients
- Russia is especially good for clinical trials when big number of patients is to be recruited in short timelines, disease is rare or drug is targeted for the Russian market.
The clinical trial market in Russia is one of the most important parts of the global clinical trial market. Russia has got the population and the prevalence of diseases which cater as a good pool of subjects in the clinical trials scenario. The high quality of the regulations followed in clinical trials in Russia leads to better optimization of clinical trials. The speed of clinical trials conducted in Russia is high mainly because of the high patient recruitment rate. The number of clinical trials conducted in Russia by foreign sponsors has tripled in the last decade. The quality of the clinical trials in Russia has been accepted by regulatory agencies such as the FDA and the EMA. One third of the data for FDA approved drugs in 2014 is coming from Russian sites. It was also observed by FDA inspection that Russia has good quality of investigators leading to low deficiency rate. Russia has caught the imagination of Big Pharma and this has led to huge investment by major pharmaceutical companies. There is improvement in the infrastructure for the conduction of clinical trials in Russia.