Quality
fundamental factor
Quality
The fundamental factor of services we provide is their high quality. We work according to the Standard Operating Procedures (SOP) that have been established based on the guidelines of the Society for Clinical Data Management (Good Clinical Data Management Practices Version 4.0). The quality system is regularly reviewed and updated as a result of regular external client’s audits.
A quality management system is not just a list of principles, procedures and methods but also proper team communication, as well as task and time management. We achieve this by using a consistent set of validated IT tools that allow us to communicate efficiently and share information, experiences, ideas.
Standard Operating Procedures we work with
Data processing
- DM001 Data Management
- DM002 CRF Development
- DM003 Database Programming and Testing
- DM004 Managing Projects Using pCRF
- DM005 Managing Projects Using eCRF
- DM006 Data Control
- DM007 SAE Reconciliation
- DM008 Laboratory Data Management
- DM009 Personal Data Protection
- DM010 External Data Management
- DM011 Database Closure
- DM012 Statistical Analysis
- DM013 Medical Review/Writing
- DM014 Sample Size Computation
- DM015 Randomization
- DM016 Statistical Analysis Plan Development
- DM017 Conducting a Statistical Analysis Project
- DM018 CDISC Statistical Programing
Processes
- PS001 Protection of Confidential Information
- PS002 Rules of storage and archiving of documentation
- PS003 Computer System Administration
- PS004 Supervision of documentation
- PS005 Supervision of records
- PS006 Corrective and Preventive Actions
- PS007 Improving the Quality Management System
- PS008 Handling the non-compliances
- PS009 Training and Training Documentation
QUALITY
Certificate
