Data Management

Our Clinical Data Management (CDM) team takes a risk-based approach to data quality oversight. We have many processes to obtain the highest level of data quality, including programmable edit checks, concurrent data review by a data manager, data quality audits, and site monitoring.

The Quintiles Outcome CDM team designs case report forms that maximize both data quality and ease of use. The team also contributes to the writing of study protocols and statistical analysis plans. Clinical Data Managers perform serious adverse event (SAE) reconciliation, chart abstraction, database audits, data review, and query generation.

The Quintiles Outcome CDM team also provides medical coding (MedDRA, WHODRUG, and other dictionaries) and SAS programming services, including creation of data listings and preparation of analysis data sets. In addition, we can provide data support services for Data Safety Monitoring Boards (DSMB) and endpoint adjudication activities and both on-site and off-site monitoring services.

• Data Collection
• Coding
• Quality Assurance
• Monitoring
• Data Transfer
• Chart Abstraction