Menu

We are apologize for the inconvenience but you need to download
more modern browser in order to be able to browse our page

Download Safari
Download Safari
Download Chrome
Download Chrome
Download Firefox
Download Firefox
Download IE 10+
Download IE 10+

Quality Assurance

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

Our Specialists:

  • Quality Assurance Manager
  • Regulatory Specialist
  • Device Study Specialist

BiTrial SOPs

  • Continuously reviewed and improved every year Audits
  • Office audits: 2005, 2008, 2009, 2010, 2011, 2012, 2014
  • Site audits: 40, btw. 2002-2013
  • EMA audit: 2011
  • PMDA audit: 2011

Due to the excellence of our QA we passed all audits without critical findings.

Hungarian Clinical
Trial Cluster

home3

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

Clinical Research
Coordination

headlinest2

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:

CE-EU Region

mapsmall

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:

logo

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.