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Clinical Trials Phase II-IV (GCP Trials)

Performing Clinical Trials in  Eastern European (EE) Countries Provides Some Unique Advantages:

  • Access to highly motivated, treatment naive and compliant patients from the more than 100 million population;

  • Rapid recruitment;

  • Access to ICH GCP experienced, English speaking, highly motivated investigational staff;

  • Very high quality of data;

  • Competitive pricing.

Staff Expertise for Conducting Clinical Trials in  Eastern European Countries:

  • 100% of Clinical Research Associates (CRAs) within this region are MDs;

  • 100% of our Project Managers are MDs having years of experience in managing clinical trials and product development programs;

  • We have excellent longstanding relationships with experienced investigators at large centers in Bulgaria and other CEE countries, including top KOLís. 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:

  • Strict adherence to ICH GCP and local regulations;

  • Regulatory and EC approvals in short terms;

  • Large number of potential patients with all types of pathology including drug-naive patient population;

  • Direct relations with Key Opinion Leaders;

  • Targeted selection of professional and motivated investigators and study staff;

  • Smooth import procedures;

  • Proven and efficient recruitment strategies;

  • Proven quality and reliability of the data;

  • Adequate data flow within required time frames;

  • Experienced and trained company staff;

  • Strict internal quality system (including written policies, standards and SOPs);

  • Competitive costs.

Project Start-Up Estimated Timelines for Bulgaria for Trials Phase II-III:

  

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Translation of study documents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Obtaining insurance

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clinical Trial Agreements

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LEC submission/approval

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RA submission/approval

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

First patient in

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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