SCiAN's Clinical Data Managers and Help Desk Support team are well-versed in clinical data management processes for EDC studies.
Sponsors who do not have in-house clinical data management support can depend on SCiAN's CDM team to:
- Build the study database
- Develop the DMP and DVP plans
- Manage database configuration changes due to e.g. protocol amendments
- Provide end-user support (e.g. help desk) and maintain end-user documents (e.g. FAQ, data entry user guides, etc.)
- Qualify, train, register and manage users
- Manage 3rd party data transfers
- Manage data exports
- Perform Medical Reviews and Data Monitoring
- Code Medical History, Adverse Events and Concomitant Medications
- Reconcile SAEs with study AEs
- Perform database lock, audit and documentation processes
- Prepare and deliver PDF versions of final eCRFs to Sites for archival purposes.