The web-based trial management system used at NIHI has an international network of more than 900 intuitional partners in over 70 countries employing the software for more than 100,000 ongoing research studies.
We have Standard operating procedures for the conduct of data management to assure quality and ensure that studies are conducted according to best practice. 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 Relational Database Management System and comes with user training options. Features include:
- Blocked/Stratified Randomisation (dynamic minimisation as a separate service)
- eCRF screens for remote data entry and real-time query resolution
- Live reporting
- Form Locking
- Participant calendar for planning visits
- Record Status Dashboard for tracking completeness of data
- Data import and Data Export
- E-monitoring for source data verification as a separate service
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.