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What is RUSSLAN Clinical Research?

RUSSLAN is a European CRO with operations focussed on Eastern Europe, particularly on the countries of the former Soviet Union. The organisation is established and run by experienced British clinical research professionals who are in charge of the crucial parts of drug development process (study design, protocol writing, project management, study analysis and report writing) and closely supervise clinical conduct of the trials outsourced to our partner clinical trial sites based in Eastern European countries. This combination of experience and expertise of “Old Europe” with capacity and enthusiasm of “New Europe” provides the most cost-effective and time-efficient solutions for clinical trial needs of our clients.

 

What are the main advantages of contracting with RUSSLAN for pharmaceutical, biotechnology and device companies?

In a nutshell, these are cost and time.

We fully understand the financial burden associated with conducting clinical trials for pharmaceutical, biotechnology and device companies. Therefore, cost-effective conduct of clinical trials for our clients is one of our highest priorities. We have full confidence that the cost of our services is among most competitive in Europe and worldwide. This is achieved due to two factors – firstly, lean and flat structure of RUSSLAN with very low overheads, and secondly, the rational choice of clinical trial sites. Typically we work with the clinical trial sites located in Eastern European countries that can deliver affordable clinical trials quickly - but without any compromises on quality.

The shortest possible time to market is another crucial factor for our clients. We have established systems that allow us to avoid delays in regulatory approvals process, and our experts armed with full knowledge of the clinical trial environment in our countries of operations ensure optimal selection and efficient management of sites that can deliver fast and efficient patient recruitment.

 

Where does RUSSLAN conduct clinical trials?

The choice of the trial site(s) depends on the features of the specific project and is based on identifying sites with the right expertise, experience and favourable cost characteristics. Some trials can be conducted in Western Europe (the United Kingdom and Ireland) but more likely (to be able to capitalise on very significant cost and time advantages), the trials are placed at carefully selected sites in Eastern Europe (Russia, Ukraine and other CIS countries, the Baltic states of Latvia, Lithuania and Estonia). In addition, RUSSLAN has dedicated partners in most other European countries.

 

Who works for RUSSLAN in Eastern Europe?

Most of our employees in Eastern Europe are highly qualified academic physicians or pharmacologists with good personal experience in independent and industry-sponsored clinical trials (often both as investigators and as clinical research professionals). All our staff are carefully selected and closely supervised. Strict procedures are employed for quality control and assurance.

 

Why have you chosen the countries of the former Soviet Union as a place to conduct your clinical trials?

Our choice of the countries of the former Soviet Union - Russia, Ukraine and the Baltic states - is based on our knowledge of the systems there, which offer many unique advantages. Below are just a few of these factors:

• Large and available patient population

• Highly centralised healthcare system with concentration of patients in large well-equipped hospitals with high capacity outpatient departments – overall excellent conditions for clinical trials

• Well educated, enthusiastic ICH GCP-trained physicians appreciating financial remuneration associated with participation in clinical trials

• High prevalence and incidence of all the major diseases and availability of treatment-naïve patients
• Patients pay for their medical treatment and are keen to take part in clinical trials

• Patients value the relationship they have with their physicians and comply well with study protocols of any complexity. Patient recruitment is fast and drop-out rates are low.

• Very good quality of clinical trial data confirmed by FDA inspections and independent audits

 

How can the clients be assured of the quality of the clinical trials conducted by RUSSLAN at the sites outside the EU?

Whilst conducting our clinical trials in the most cost-effective manner, the quality of our trials remains our main concern. Our local experts based in Eastern Europe have extensive knowledge of quality sites and good investigators in all main therapeutic areas. RUSSLAN works only with the sites that hold full governmental accreditation and meet our own strict criteria on expertise, experience and ICH GCP compliance, and are able to demonstrate a proven track record of efficient patient recruitment.

When we select a site, it means the start of a very close partnership between us. If after our thorough inspection, we are fully satisfied with the credentials of a particular site, we do not stop there – we help the site to grow and develop, we provide additional GCP training for investigators and organise close supervision at each stage of the clinical trials they conduct for us. In addition, we always aim to help Eastern European investigators to establish academic connections with their colleagues in Britain; we try to promote collaborative academic projects and mutual educational visits.

 

Who works for RUSSLAN in Western Europe?

The nucleus of RUSSLAN’s expertise and experience is based in Great Britain. Our senior managers and consultants have extensive expertise in all aspects of clinical trials from study design through regulatory approvals and management of clinical conduct to data management, biostatistics and medical writing.

We are proud to have on board at RUSSLAN academics associated with leading British universities. Our corporate CV (available on request) features a large number of publications in peer-reviewed international journals in various fields of medicine and medical psychology. Our representatives speak regularly at major conferences on topics related to clinical trials and their respective therapeutic areas of expertise.