DATA MANAGEMENT

WE’LL HANDLE THE DATA

BCG data management processes are 21 CFR Part 11 compliant and user-friendly — ideal for paper CRFs, EDC-based projects, and rescue studies. We start by deploying a data capture system, then build the study database, review and verify data, and format it for submission to regulatory authorities — with database lock on or before deadline — every time.

DATA MANAGEMENT PLANNING

• Data management plan creation and maintenance
• Data entry guideline / eCRF completion guideline creation and maintenance
• Site / CRA EDC training
• CRF / eCRF design
• Implementation of current data standards (SDTM, CDASH, and other CDISC standards)
• Customized clinical data management programming
• Data management consulting

DATA MANAGEMENT SERVICES 

• Data entry and tracking
• Data conversion to proprietary data specifications
• Process and resolve queries
• CRF review and validation
• Medical coding and serious adverse event (SAE) reconciliation
• Clinical trial rescue services

DATABASE CONFIGURATION

• Database development, testing, and deployment
• Database closeout and delivery
• Clinical database exports and interim analyses
• User access management
• Customized status reporting and data listings