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Clinical Trials Phase II-IV (GCP Trials)
Performing Clinical Trials in
Eastern European (EE) Countries Provides Some Unique Advantages:
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Access to highly motivated, treatment naive and compliant
patients from the more than 100 million population;
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Rapid recruitment;
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Access to ICH GCP experienced, English speaking, highly
motivated investigational staff;
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Very high quality of data;
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Competitive pricing.
Staff Expertise for Conducting
Clinical Trials in Eastern European Countries:
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100% of Clinical Research Associates (CRAs) within this
region are MDs;
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100% of our Project Managers are MDs having years of
experience in managing clinical trials and product development programs;
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We have excellent longstanding relationships with
experienced investigators at large centers in Bulgaria and other CEE
countries, including top KOL’s. This helps us to identify the most
appropriate, highly motivated and experienced sites with access to
appropriate patient population for conducting clinical trials for our
Customers.
We Are Glad to Offer to Our
Customers:
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Strict adherence to ICH GCP and local regulations;
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Regulatory and EC approvals in short terms;
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Large number of potential patients with all types of
pathology including drug-naive patient population;
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Direct relations with Key Opinion Leaders;
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Targeted selection of professional and motivated
investigators and study staff;
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Smooth import procedures;
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Proven and efficient recruitment strategies;
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Proven quality and reliability of the data;
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Adequate data flow within required time frames;
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Experienced and trained company staff;
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Strict internal quality system (including written
policies, standards and SOPs);
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Competitive costs.
Project Start-Up Estimated Timelines for
Bulgaria for Trials Phase II-III:
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Translation of study documents |
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Obtaining insurance |
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Clinical Trial Agreements |
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LEC
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RA submission/approval |
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First patient in |
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