Esoterix Clinical Trials Services, Inc.

Data Management

Esoterix Clinical Trials Services' data management system provides flexibility for sponsors in retrieving information for data management and clinical development departments, as well as investigators. With a worldwide setup and single global database updated in real time, no end-of-day merging of data is required. Our system provides clean, combined data for either management reports or data sets. Data integrity is further maintained through automatic edit checks. Both data sets and management reports can be customized to meet the needs of your study. Data is available in the following formats
  • ASCII
  • Microsoft® Excel
  • SAS®
  • Microsoft® Access
  • Oracle®

Bar-coded requisition forms are customized for each study, allowing for complete specimen tracking through all phases. Esoterix Clinical Trials Services' audit trails help preserve quality across the board, facilitating expedited submission of quality data with complete audit trails of all study events.

Esoterix Clinical Trials Services data management system is validated and compliant with the Code of Federal Regulations Title 21 Part 11 for electronic records. A flexible format allows for data elements to be added to a file layout without substantial coding. Data integrity is further maintained through automatic edit checks. Redundant storage areas reduce the risk of data corruption, and our Oracle database ensures that demographic changes will be consistently carried across all visits.