Our state of the art web-based trial management system has been used for over 60 studies since 1999
We have Standard operating procedures for the conduct of data management to assure quality and ensure that studies are conducted according to best practice. The NIHI and our systems are ISO-9001 certified.
We assign a Data Manager who will work with you for the whole study from design and setup to data lock. Our team of experienced Data Managers have skills in electronic and paper CRF design, data validation, adverse event reconciliation, coding (MedDRA, ICD-10, WHO-ATC and other classifications), data extraction, electronic import of data such as laboratory results, query resolution, database lock and study closure.
Our online system uses Oracle databases and comes with user training options. Features include:
- Randomisation (stratified/blocked/dynamic)
- eCRF screens for remote data entry and real-time query resolution
- Endpoint tracking and adjudication
- Live reporting
- Real-time safety alerts
- E-monitoring screens for source data verification
- Participant calendar for planning visits and tracking completeness of data
Our servers are housed in a purpose-built computer centre with high levels of security and systems redundancy.
For more information on the NIHI's Data Management Services, please contact Michelle Jenkins, Lead Data Manager.
We have a demonstration site at www.nihi.auckland.ac.nz/demo