Why CLS?
Active Site Network
■ ■ ■ CLS manages national and international networks of clinical sites in several therapeutic areas which allow us to minimize the start-up period. We have active Site Networks in the areas of Obstetrics & Gynecology, Internal Medicine, Oncology, Ophthalmology, Dermatology, Inflammation, and Surgery. In addition, we have established cooperation with a few advanced Phase I Units. ■ ■ ■
Reliable Feasibility Process
■ ■ ■ Feasibility as a part of a study start-up determines the future course of the study. We identify the clinical sites that can provide intensive and high-quality recruitment. We simplify the challenging task of finding appropriate sites in the very beginning by exploring our network. Sometimes, the clinical site can be very successful in one indication but weaker in another. For new indications, we reassure the site potential which ensures quicker and higher enrolment. ■ ■ ■
Geographical Coverage
■ ■ ■ Our geographical coverage extends to the Eastern part of the European continent. Ukraine is a key area for coordinated studies within this geographical region which, if necessary, extends to Moldova, Romania and Georgia, where we are actively developing a network of clinical sites. In addition, CLS has established strategic partnerships in the Netherlands, Poland and Bulgaria which noticeably expands the total geographical area of our operational activities. ■ ■ ■
CRO/SMO Strategy
■ ■ ■ As a CRO/SMO, CLS has focused on the region of Eastern Europe. In some therapeutic areas, CLS Network operates on up to 100% of the territory and provides medical coverage for up to 80% of the population. This makes it more than 100 million in size that results in quicker and higher enrolment. Active exploiting of our Site Network ensures reliable feasibility and provides a quick start-up. In our approach having the established site management means establishing interpersonal relations between the company’s and site’s personnel to make the operational part of a trial fully predictable and easily manageable. ■ ■ ■
Excellence
■ ■ ■ The CLS Excellence Program guarantees that our staff is highly experienced and regularly trained in ICH-GCP guidelines and that study conduction and documentation quality are on the highest level. Excellent tracking of records together with established site support tools, facilitated proactive problem solving, teamwork, and focus on quality ensure the validity of the in-out parameters. The Go/No-Go decision-making moment is supported by risk analysis and relevant contingency plan. ■ ■ ■
Strengths of Targeted Market
■ ■ ■ CLS Site Networks are built mainly in the post-Soviet territories (ex-USSR) within a supportive regulatory environment. The doctor–patient relationship is a central part of healthcare practice in this region which is very favourable for clinical trials. Another benefit 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 to the company employees. ■ ■ ■
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