Data Management/EDC
Specialized Services and Technologies for Your Study
When it comes to clinical trial success, data integrity is key. Our clinical data management experts are committed to providing the highest data quality, integrity, and security for our clients. Using industry-leading electronic data capture (EDC) technologies, SDC provides end-to-end clinical data management support from eCRF design through database lock and final study archival.
SDC is a CDISC Registered Solutions Provider for CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards.
Data Management Services
- Protocol Review
- Optimal Technology Solution Recommendation
- Risk-Based Monitoring Strategies
- 24/7 EDC Helpdesk
- EDC Access Administration
- Data Management Trial Master File Set-Up and Maintenance
- CRF Design and Development
- CRF Completion Guidelines (CCG) Development
- Subject Diary Design and Development
- Data Management Plan Development
- Data Validation Manual Development
- EDC System Training for Sites and Monitors
- Clinical Database Creation, Validation and Auditing
- Edit Check Programming, Validation, and Testing
- Development of Custom Status Reports
- Adverse Event, Concomitant Medication, and Medical History Coding
- Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
- Continuous Data Cleaning Throughout Study
- Query Reconciliation
- Independent QC Review
- SAE Reconciliation between Safety and Clinical Databases
- Database Lock
- Study Archival
Technology Solutions
We leverage industry-leading technologies to provide the most efficient solutions for your study. Our preferred technology platforms include iMedNet eClinical, Medidata Rave, and Veeva Vault EDC. In addition to these technologies, SDC frequently supports studies in a variety of other eClinical platforms upon request.
