Multilingual Clinical Trial Management System

Challenge

Our customer is a clinical research organization (CRO) that wanted to develop a clinical trial management system (CTMS) for remote regions, which implies that the system has to be accessible without an internet connection and support multiple languages for every user role.

Regardless of the user base, the development of new drugs and therapeutic methods are very regulatory-intensive processes that require compliance with a range of medical standards and practices.

Given our comprehensive experience in developing electronic data capture (EDC) and CTMS solutions, the customer turned to Virtual Nomad for consulting and the consequential development of the platform.

Solution

As firm advocates of open-source software, we decided to use Open Clinica as the platform’s basis. Given that the system was intended to be used by people with either unstable or no internet access, the implementation of interactive voice response (IVR) system that would allow users to interact using touch-tone digits or their voice was crucial. So, on top of the web-based EDC, we also implemented an Asterisk-based IVR module.

To ensure that the platform can be equally accessed by people speaking different languages and that the database is easy to interpret by non-English-speaking users, we adopted the Medical Dictionary for Regulatory Activities (MedDRA), a multilingual dictionary of the standard terminology that is used to code medical events in humans, including patients’ medical histories and adverse events. We also refactored OpenClinica’s core platform to remove certain limitations that didn’t allow non-English languages to be used.

The system supports the following user roles:
– Data Manager
– Clinical Research Coordinator
– Monitor
– Investigator
– Medical Coder

Result

Virtual Nomad delivered an open-source, web-based, and fully compliant EDC/CTMS solution with IVR support. The platform significantly streamlines data gathering, analysis, and management for clinical trials, allowing medical professionals from distant regions to reveal new opportunities in clinical research.