Quality Assurance
Our high standard of quality, value, and performance is maintained using a proactive quality assurance model.
Quality & value
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, 2016, 2018
- Site audits: 60, btw. 2002-2019
- EMA audit: 2011
- PMDA audit: 2011