Clinical trials solution — Overall clinical trial automation

This 56 000 man-hours .NET-based solution provides all the functionality clinicians and scientists, conducting clinical trials, could even think of.

The system consists of eight applications, which can work separately, embodied by generic user roles and rights management:

1. Data Capture and Validation module, ensuring Electronic Data Capture (EDC) and manual validation procedures. It stores info on all the participants, medicines, procedures and tests related to the trial.
2. Trial Management, ensuring Serious Adverse Event (SAE), Protocol Exception and Protocol Violation management.
3. Document Management, used for managing document flow related to clinical trials. It stores all information about licensing and certificates necessary to conduct clinical trials.
4. Supply Management module, enabling wholesale medications and expendable materials purchase.
5. Biorepository Management, ensuring samples-related data storage and retrieval. This is one of the most important parts of the system, since storing and managing biospecimens and associated information is at the core of any clinical trial. After scanning the sample barcode with a barcode scanning device, clinical and phenotypical information about the sample is transferred into the system, and parametric search across the scanned specimens becomes available. The system unifies a network of multiple biobanks, ensuring a much larger collection that could be owned by any single institution.
6. Statistics and Analysis, allowing to see clearly the dynamic of the studies.
7. Intranet Portal, helping to reach employees, delivering them news, and providing knowledge sharing.
8. Financial Module, allowing to calculate billable events for future purpose of creating invoices, statistics about number of visits/procedures is gathered from the EDC.