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.
