The Data Management Unit provides high quality, independent data management services that comply with the world’s best industry standards (International Conference on Harmonisation guidelines for Good Clinical Practice). The Unit works with researchers and university departments to provide data support, ensuring accurate and reliable information. Providing Clinical Data Management services, the Unit accommodates a wide variety of studies. These include data management for academic databases, large registries/repository data and single- and multi-centred Phase I-IV clinical trials for the pharmaceutical industry.
The Unit uses the ClinPlus clinical data management system licensed from DZS Software Solutions. This comprehensive SAS®-based system complies with the Code of Federal Regulations (CF) code 21, part 11. It allows a flexible approach, enabling tailored solutions for all study design needs, including paper-based, electronic data capture (EDC) or a combination of the two within the same study. The system also provides a full internal audit trail.
The Data Management Unit’s staff members have more than 20 years of experience in clinical research organisations and academic institutes.
Data Management Unit
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring St, Melbourne, VIC 3000
T: 1800 850 622 F: +61 3 9663 5726