The web-based trial management system used at the NIHI has an international network of more than 4900 institutional partners in over 140 countries employing the software for more than 1 million 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.

We assign a Data Manager who will work with you for the whole study from design and setup to data lock. Our team has 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 a Relational Database Management System and comes with user training options. Features include:

• Blocked/Stratified Randomisation
• eCRF screens for remote data entry and real-time query resolution
• A companion app specifically for offline data collection in environments with poor internet connectivity, with a data upload function to the server at a later point when internet connectivity is available
• Live reporting
• Form Locking
• Participant calendar for planning visits
• Record Status Dashboard for tracking completeness of data
• Data import and Data Export

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 Lead Biostatistician Varsha Parag.