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Our high standard of quality, value, and performance
is maintained using a proactive quality assurance model.
Our high standard of quality, value, and performance is maintained using a proactive quality assurance model based on redundant data and process review that incorporates documented internal monitoring, client surveys and feedback, and outside auditing.
This model ensures that BiTrial activities meet the regulatory requirements
and guidelines, such as:
Principles of Good Clinical Practice
ICH guidelines
US 21 Code of Federal Regulation relevant sub parts
EudraLex Volume 10 Clinical Trials guidelines
Other EU directives
Local legislations and ethical principles
Due to the excellence of our QA we passed all audits without critical findings.
BiTrial Clinical Research is charter member of the first Hungarian Clinical Study Cluster (HCSC) established with the purpose of developing close relationships between participant members in order to improve quality and capacity in all aspects of drug development and clinical trial conditions
Our strategic partner, Clinical Research Coordination Ltd., is the market leader Study Management Organization (SMO) in Hungary. Clinical Research Coordination Ltd. is present in about 13 hospitals and provides a unique support to sponsors and investigational sites by ensuring:
BiTrial Clinical Research is a privately owned mid-sized Clinical Research
Organization (CRO), based in Central and Eastern Europe with
a headquarter in Budapest, Hungary.
