CDM-EDC

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.