Patient safety and quality data underpin everything we do. The Medical Technologies quality team ensures that our processes are robust and patient data is complete and accurate.
The Medical Technologies team understand that effective quality management system can allow to minimize a number of potential risks. Our company pays great attention to quality.
Medical Technologies is recognized as a leader in quality assurance and compliance by many Sponsors. We have developed our own Medical Technologies Quality Management Systems to ensure quality. All the sites within the Medical Technologies network work under the same Quality Management System.
We continuously work with CROs and pharmaceutical companies to update our operating procedures, providing a continuum of process improvements that ensures compliance with regulatory, ethical and ICH GCP requirements and clients’ expectations.
The Medical Technologies Quality Vision is to continuously achieve the best quality standards to provide the highest service to clients and patients.
The quality management system includes:
- Quality Vision
- Organizational structure of the company
- Standard Operating Procedures, Policies, templates and standard forms
- QA and QC controls
- Staff training
- Performance assessment
All QMS documents of the company are stored in an electronic system, LMS, which allows all employees to have online access to documents at any time. In addition, we maintain electronic personal folders of the employees, which allow us to track due and timely data updates. The electronic systems we use have been validated and audited by our quality department.
We pay attention to the selection of reliable vendors. We perform vendor audits before working with them.Every year we perform analysis of feedback from customers and suppliers. Our team is in constant contact with CRAs and CTAs from CROs and pharmaceutical companies to improve our quality and performance.
We also pay a lot of attention to the feedback o fauditors and inspectors from Regulatory Authorities.
One of the sites within the Medical Technologies network, «BioEq», has successfully passed several inspections:
- In October of 2014 the regulatory inspection (by the RosZdravNadzor – the Federal Service on Surveillance in Healthcare of the Russian Federation) was conducted at «BioEq» with no major or critical findings in clinical trials conducted at the site.
- In July of 2016 another regulatory inspection (by the RosZdravNadzor – the Federal Service on Surveillance in Healthcare of the Russian Federation) was conducted at «BioEq» with no major or critical findings.
The sites of the network went through more than 20 CRO/Sponsor clinical study audits.