Clinical Data Management
S-cubed performs the full suite of Data Management services from planning and documentation (Data Management Plan and Data Validation Plan), CRF (EDC or paper) design and testing, Diary Card and database design, double data entry, discrepancy management, medical coding, SAE reconciliation, database lock. S-cubed can perform all of these services for a client or act in a consultancy basis on particular aspects.
Our Data Management staff have a vast amount of experience on a variety of database systems and are happy to work on a client’s preferred database solution or provide S-cubed’s solution.
S-cubed’s clinical database solution is OpenClinica. OpenClinica has a large user community (>18,000 people) in over 100 countries, and is used by a wide variety of pharmaceutical, biotech and device companies. It is a user-friendly fully validated 21 CFR Part 11 compliant internet-based system which can be accessed via a range of devices. OpenClinica allows electronic data capture at clinical sites as well as traditional paper entry (or a hybrid approach). OpenClinica also has an ePRO capability with subjects able to enter data (e.g. Questionnaires) directly onto the database via their smart phones or other mobile devices.