Development and validation of an information management system for suspected cases in clinical trials
A client would like to introduce an IT system, which can provide information about suspected cases of unexpected, severe side-effects during clinical testing on time and in a focused manner. Among other things, the regulatory requirements should be fulfilled. The system should be validated, flexible, highly-automated and designed for a high volume of data and should also contribute to cost reductions. The recipients of information, in electronic or printed form, are clinical trial managers, investigators and ethics commissions all over the world.
The client is commissioning EXCO with the development and validation of an individual information management system to depict the necessary workflows.
EXCO implements the entire life cycle of the system:
- Project management
- System analysis
- Technology consultation and selection
- Technical design
- Risk analysis
- Development of the application
- Qualification and validation of the application and system
- Creation of training documents and user training
- 2nd and 3rd Level Support
- Multi-tier application with thin-clients
- Scalable architecture for further system expansion
- Connection to the document management system
With this client-specific software, EXCO is ensuring that the information about reportable suspected cases is passed on completely, accurately, transparently and efficiently.
- Minimization of process cycle times.
- Significant reduction in print and dispatch costs.
- Authorities inspected the system several times without any complaints.
Pharmaceutical company, Neuss
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