- Expertise BioVirtus can execute large long-confinement studies with up to 45 subjects.
- Effectiveness Thanks to a large database of subjects BioVirtus guarantees swift and effective recruitment, screening and enrolment.
- Easiness We have the ability to quickly enrol patients with various diseases.
Why choose us
Quality Assurance and Quality Control
Thanks to our experienced and highly qualified QA&QC teams which consist of our Quality Assurance Consultant and Quality Control Specialist
as well as implemented internal quality systems we can provide the following processes which guarantee the highest quality of projects conducted
at the BioVirtus Research Site:
- a system of internal documentation assuring quality and standardization
of procedures: Standard Operating Procedures (SOPs), general
and study-specific instructions - regular internal verification and update of SOPs
- verification of operations compliance with local and international regulations
and guidelines (ICH GCP, EMA and FDA guidelines, etc.) - regular general and study-specific trainings (GCP, emergency procedures, etc.)
- internal and external checks, validation and certification of equipment.
Our key personnel have participated in many external audits as well as in regulatory inspection.
BioVirtus developed its own SOP system covering all key processes and activities.
Our SOP system is divided into the following sections:
- Pre-study activities
- Study conduct, safety and site organization
- Pharmacy procedures
- Organization and administration
- Quality Assurance
- Biological samples handling and processing
- IT.
