Data management is one of SOCAR’s core services which are provided following ICH, GCP, and regulatory agency guidelines, using controlled and secure computing environments with validated software and systems (21 CFR Part 11 compliant) and well-designed workflow processes and procedures.
SOCAR achieves efficiency and assures quality through the combination of using eSOCDATTM
and well-defined standard operating procedures, including the use of templates for standard CRF/eCRFs, data management plans, user acceptance test plans, data review checklists, database quality acceptance sampling plans, database lock checklist sign-off sheets.
SOCAR has implemented a true multidisciplinary approach to Data Management activities, allowing for the delivery of complete and accurate data in the most time-efficient manner while maintaining and ensuring that all the principles concerning data integrity are met to the highest standard.
The data management workflow is data-driven and streamlined using detailed task lists. Scheduled visits and multiple data records (e.g. concomitant treatments, adverse events) declared ‘clean’ and complete following the data cleaning process are ‘soft-locked’ on an ongoing basis.