Data Management

SOCAR's data management systems and technology (i.e. e-SOCDAT™) offer a true multidisciplinary approach allowing delivery of complete and accurate data in the most time efficient manner while maintaining the highest data quality.

This approach enables simultaneous medical and non-medical data checking which increases productivity and accelerates the time to database lock. During the data management process, e-DCFs are created as required, with automatic notifications sent to site personnel for e-DCFs requiring urgent resolution. 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 'locked' on an ongoing basis.

This approach to data management ensures the availability of accurate and complete data for interim analyses and/or status reports which may be required during the conduct of a research project in addition to reducing the time to final database lock after the last patient visit.

SOCAR's data management services include:

Design, development and implementation of the research study database (paper based or electronic data capture) according to clients specifications and industry standards (e.g. CDISC, ODM)
Testing and validation of each research project database according to well-documented procedures such as ICH GCP predicate rule requirements, laws, and regulations for clinical trial conduct, FDA CSUICI guidance and General Principles for computerised systems validation and FDA 21 CFR 11 for electronic record and signature use
First and second data entry (if requested for paper-based clinical studies)
Data query management
Data tracking
Data quality assurance and quality control until final database lock
Coding of medical conditions, adverse events and concomitant treatments and indication for drug use
Planning and organisation of Blinded Data Review meetings in preparation of database lock

Data Management
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