Clinical Data Management

A Sponsor's "in-house" CDM Team

SCiAN's Clinical Data Managers and Help Desk Support team are well-versed in clinical data management processes for EDC studies or traditional paper 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.