The role of data management in the clinical development process is essential; it directly influences the quality of data received from Investigative sites and the quality of data delivered to the statistical and medical writing groups. Therefore, an interactive collaboration between data management and other disciplines of the clinical development process must be achieved. Integrium’s Data Managers average 20 years experience in the pharmaceutical and CRO industry and have worked from phase I to phase IV projects in both full service and stand alone, EDC or Paper-Based CRF projects, achieving the collaboration necessary for successful results.

Our heightened attention to every detail has resulted in a successful history of completing data management tasks on time and within budget. With this depth of experience, we have the processes and policies in place to effectively focus on high-quality results. Our Data management specialists are actively involved and accessible from study start to finish in order to ensure that the data captured support overall objectives and all necessary regulatory requirements.

Integrium staff has work on multiple EDC platforms including PhaseForward, PDS, DataLabs, DSG and ClinPlus Data Management in EDC mode in the past years. In 2009, Integrium locked all of their clinical EDC databases on time or before the projected Database Lock date.

For paper-based CRF trials, Integrium uses ClinPlus Data Management (CPDM) a comprehensive, 21 CFR Part 11 compliant, SAS®-based system specifically designed for managing clinical trial data, from single studies to major projects.

Our data management services include:

• Case Report Form (CRF) design
• Database design
• Data management plans/guidelines
• CRF management
• Double data entry (when Paper CRFs are used)
• Data validation and review
• Medical coding (WHO, MedDRA®, etc.)
• Edit checks and data queries
• Electronic data processing/reconciliation
• Data migration