Data Management

Statistics & Data Corporation (SDC), Ora’s bioinformatics division, can provide you with a seamless flow of data and a constant level of communication, ensuring that your projects meet all milestones and deadlines.

SDC’s data management services include:

• Data Management Trial Master File Set-Up and Maintenance
• eCRF or 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, and Testing
• Self Evident Correction Listing
• Data Entry Guidelines
• Clinical Database Creation, Validation and Auditing
• Double Data Entry and Verification
• CRF Tracking and Audit Trail Documentation
• Data Clarification Form Generation and Resolution
• Adverse Event and Concomitant Medication, and Medical History Coding
• Import, Integration, and Cleaning of electronic data (Lab, ECG, PK, Diary, etc)
• Independent QC Review
• Development of Custom Status Reports upon Request
• Scanning of Paper CRFs and Trial Master File available.
• SAE Reconciliation between Safety and Clinical Databases

 To learn more about SDC, please visit www.sdcclinical.com.