CLINICAL TRIALS NETWORK SYSTEMS.
Until now, clinical trials, conducted to support registration of medications, have been a major administrative task. The setup, monitoring and finalizing tasks to accomplish such multi-country studies involve a lot of work, part of the sponsors and their monitors, part of the investigators.
It is clear that a big opportunity exists for automated and computer-assisted clinical trial management systems. Archtects and Algorithms developed a sophisticated, MS-Windows based data management system that provides a pharmaceutical company with an easy to use, fault-tolerant method to collect, validate and monitor the vast amounts of data, generated by geographically dispersed sites.
The concept of the system allows to built a network of interconnected investigators, monitors, study sponsors and study auditors.
- Database Management
The large amount of data collected during a study, involves important requirements concerning data base management and data handling. Validating medical information is a complex subject. To simplify the monitoring of the information, separate data validation systems will have to be developed. The CTNS solution will be a catalysator for medical expert systems being able to analyse medical data.
- Information Distibution
Each CTNSstation is connected trough a wide area network, with each other station. This network can not only be used for study data collection, but also as a new communication medium between research organisations and individuals The challenging requirements for data- and information security, system reliability imposed by authority rulings, means that the experience with the implementations of CTNS systems, will contribute to the general knowledge concerning data distribution.