Our Standarts
We are continuously aiming to achieve the best quality standards in order to provide the highest quality of accurate and verifiable data to our partners in accordance with the regulatory, ethical and ICH GCP requirements by implementing:
- Quality system Documents (SOPs)
- Ongoing trainings and evaluation of the study coordinators and the site investigators
- Ongoing external certification
- Maintenance of the study documentation according to the Good Documentation Practice
- Clinical Trial materials storage and accountability according to the Protocol
- IMP storage and accountability according to the Protocol
- Study documentation archiving
- Maintenance and calibration of the equipment, used within the study
Numerous CRO and Sponsor’s audits, conducted at Bio Medical Services’ sites as well as System audits, conducted at Bio Medical Services’ facilities with no Critical or Major findings as a result.