The discipline of data

Data management is essential in clinical development and it influences the quality of data received from investigative sites and of that delivered to the statistical and medical writing groups. So an interactive collaboration between data management and other disciplines of the clinical development process is needed. Integrium’s Data Managers average 20 years of experience in the pharmaceutical and CRO industry and have worked on a wide range of projects both full service and stand alone, EDC or Paper-Based CRF projects. So they are used to achieving the collaboration necessary for successful results.

Our meticulous attention to detail has resulted in a successful history of completing data management tasks on time and within budget. And it is this depth of experience that ensures we've got the processes and policies in place to effectively focus on high-quality results. Our data management specialists are actively involved and accessible from start to finish in order to ensure that the data captured support overall objectives and all necessary regulatory requirements.

Integrium's staff has worked 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