ASCOPHARM has developed a large expertise in the production and follow-up of randomization systems. Within the last ten years, and with the support of IT specialists, ASCOPHARM has now mastered a number of systems which include:
- Vocal Randomisation Systems through telephone,
- Web-based Randomisation Systems,
- Fax-on-Demand Randomisation Systems,
The three different techniques may be associated and function with a central unique Oracle data base.
Specific scenarios permit to acquire all inclusion/exclusion information, and high quality vocal messages are produced for all vocal systems. Automatic fax, e-mail or SMS sending provide documentation to randomisation.
CRF superposable formularies are produced for web-based randomisation systems which becomes now the most effective system and less expansive tool. Multiple e-mail alerts are always an important strength of the system.
Fax randomisation tools are also widely used especially in oncology and provide a good documentation whenever needed.
Randomisation algorithms are produced by our Statistic department and integrate all state of the art complex techniques, including stratification and minimisation.
Powerful interface between randomisation system and information tools (multiple automatic mails, fax, SMS, ftp transfers, etc…) permit a number of side applications such as analytic product accountability, products and documents re- provisioning, automatic update of study follow-up tools (information web site, follow-up charts, etc..), and documentation of audit trail of the system.
Randomisation servers include:
- 2 dedicated powerful computer servers with RTS inteface and 8 entering phone lines per server which provide a capacity of up to 2300 randomisation per day.
- 1 dedicated powerful web server for the management of web-based applications,
- 1 dedicated multi-processor server which provides the Oracle 10i DB server,
- Secured networking between servers and high protection agains intrusion and power loss.
- Easy interfacing with project follow-up when project is under ASCOPHARM NOVASCO Group responsibility.
Complete validated development of a randomisation server for a specific study may be performed within 15 days in a quality and cost-effective manner.