Our services

clinical data management

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.

with our
data management

Our Data Management team is flexible, collaborative and built to produce with a problem solving approach.
We work closely with our partners to gain insights into needs and provide system recommendations based on the size, scope, and complexity of your clinical research project.
SOCAR has value-added technologies (i.e. eSOCDATTM) to support our partners achieve faster start-up times for studies, shorter database lock time and availability and last but not least, to make the overall data management experience a better clinical experience.

our clinical data management services include

(using eSOCDATTM )
Case report form (CRF) design, CRF Annotation & Review
Database Build & Design
Data validation specifications ensuring validation of all system components throughout the study period as modifications are introduced
Edit checks on programming, testing and validation
Query Management in combination with statistical checking of within - and between - patients
Variability thus gaining an in-depth, and thorough quality assessment, checking for data errors or trends and querying data over the life cycle of the research project through to final database lock
Safety data review and reconciliation of adverse events and serious adverse events
Medical terminology coding using MedDRA and medication coding using WHODrugTM Dictionary
Data Export/imports/Transfer
CDASH Compliant deliverables
Real-time data viewing and reporting
Electronic data capture (EDC) systems implementation and training
Database QA acceptance sampling prior to database lock, and additional statistical database checks
Secure web portal (i.e. eSOCDATTM) for role-restricted real-time access to study progress reports, query reports, subject data listings and summary tables, etc.
Ongoing support for users of data management systems and tools, including user training and helpdesk operation
All activities relating to database lock, decommissioning and archiving.