TENALEA services for randomisation and registration
The TENALEA randomisation service has gone through several cycles of development over the past two decades. It has been validated by 20 data centres throughout EU member states, tested by the pharmaceutical industry, and has been localised to meet their functional and operational requirements.
The software package which supports the online patient registration and randomisation in TENALEA Services is called ALEA. It was developed to meet the needs of four of the largest Data Centres for cancer trials in Europe. The current software draws on extensive operational experience amassed since the 1990s and is suitable for virtually any trial in health care. ALEA has been built as a series of components, in order to support interoperability and customized extensions. The components make use of a common standard representation of data and metadata: the Operational Data Model of CDISC. Within ALEA, the components share a database for storing and retrieving information about the trial, and a separate database for storing and retrieving patient data. Further information about each module is available from the links on the left.
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