Clinical Services > Clinical Data Management

Clinical Data Management

 

We recognize that data integrity is the key to success of any clinical study, whether your trial is a large international study or a single center proof-of-concept trial.

Working together with our partners we provide a seamless flow of data and constant communication to meet all project deadlines and milestones. Our data management experts understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.

Key advantages to partnering with PRC Clinical for Clinical Data Management (CDM) include:

  • Extensive libraries of standard eCRFs & edit checks
  • Experienced, driven project teams that require minimal oversight from Sponsors
  • Seamless interaction between Data Management and Clinical Operations teams
  • Expedited study start-up & close-out timelines
  • Developing and regularly updating full SOPs (Standard Operating Procedures)

Our Clinical Data Management (CDM) Services Include:

  • Data Management Trial Master File Set-Up and Maintenance
  • eCRF / CRF Design and Development
  • CRF and Diary Completion Instructions
  • Subject Diary Design and Development
  • Data Management Plan Development
  • Data Validation Manual Development
  • Edit Check Programming, Validation, & Testing
  • Clinical Database Creation, Validation, & Testing
  • EDC System Training for Sites & Monitors
  • Adverse Event and Concomitant Medication, and Medical History Coding
  • Import, Integration, and Cleaning of electronic data (Lab, ECG, PK, Diary, etc)
  • Independent QC Review
  • SAE Reconciliation between Safety and Clinical Databases
  • Development of Custom Status Reports
  • 24/7 EDC Helpdesk