Our Services
Study Design & Start-up
This includes the development of the investigational program, study designing, study documents development, medical writing. A team of internal and external experts, key opinion leaders and potential investigators upon necessity is actively involved in study designing to provide a state-to-art approach, which ensures that all the latest scientific and medical information, as well as all small details, are taken into account.
Regulatory Services
Includes the development of the Application file, full support in obtaining Regulatory Approvals in State regulatory bodies, LEC/IRB submission support, pharmacovigilance, and SAE reporting.
Clinical Operations
Starting from the reliable feasibility and to close-up, our experienced operation team ensures a proper conducting of the study. Clinical monitoring, site management, site education, other on-site and remote activities support the data quality, patient safety, and the study timelines adherence.
Site Management
In any trial proper day-to-day management of sites’ activities ensure effective conducting of studies. We just not only maintain routine processes like contracting investigators and institutions, finance management, issue solving but also have developed our own system of central and regional support of site coordinators (medical and operational), educational programs for investigators, and coordinating the network of referral sites.
Preclinical Development
Preclinical research is an essential part of R&D program in the development of any new medicines. We manage pre-clinical toxicology, pharmacology and pharmacokinetic studies by involving local GLP laboratories and leading independent experts and are able to propose cost- and time-effective solutions.
Proof of Concept Studies
Sometimes, the program for the development of a new drug requires an additional set of supplementary research that goes beyond the study of a given molecule and makes it possible to substantiate a hypothesis why this new drug needs to be created and why it will work
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Strengths of Targeted Market
■ ■ ■ CLS Site Networks are built mainly in the post-Soviet countries (ex-USSR), with a supportive regulatory environment. The doctor–patient relationship is a central part of healthcare and the practice in this region which is very favourable for clinical trials. Another angle is a large number of the treatment naïve patients.
Both the company and sites are staffed with experienced experts having medical degrees (MD) including Site Coordinators. Experienced, flexible and manageable Principal Investigators provide full support of the company’s employees. ■ ■ ■