Data Management
Database Design and Build
We build clinical databases in a variety of systems, either with our database solution, OpenClinica or a client’s preferred database system.
Typically, our build process is rapid, ensuring you get from protocol finalization to go live as quickly as possible. If things change, we can implement protocol amendment changes without fuss and with paramount importance. The eCRF design, system testing and user training will ensure your team is confident from the first participant.
OpenClinica
We regularly database and report studies using S-cubed’s clinical database solution, OpenClinica. OpenClinica is used internationally by a wide variety of pharmaceutical, biotech and device companies. It is a user-friendly, comprehensive, fully validated 21 CFR Part 11 compliant EDC system which can be accessed via a range of devices. Through it’s range of additional modules, ePRO and randomisation can be incorporated with ease. For further information see: www.openclinica.com
Data Management and Cleaning
We perform the full suite of data management tasks which are essential for accurate study reporting. Our quality driven approach drives our entire process from the planning and implementation, including vital documentation (Data Management Plan & Data Validation Plan), the on study activities of data entry, external data integration, discrepancy management and SAE reconciliation, through to the database lock cleaning tasks, ready for the creation of CDISC compliant SDTM datasets.
Medical Coding
Our data managers have many years experience in coding using MedDRA, WHODrug and ATC. We are also able to up-version already coded data to newer dictionaries which is often required when pooling data.
Contact us
- We are ready to support you in reaching your goals, contact us today.