Announcements - ALEA becomes TENALEA Randomisation and TENALEA...

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ALEA becomes TENALEA Randomisation and TENALEA eCRF

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After a final round of updates and testing of software, courseware and documentation the new release of ALEA was ready for the final audit. But before it could be audited as an online service, its new operational envrionment needed to be in place and in operation in compliance with the new TENALEA QA system.

And ready it was: the external auditors have assigned the long awaited audit certificate to the new version of ALEA, which was received 20 november 2009.

After the release of ALEA 2.2 in 2005, it took over 4 years to come to a new major release of the ALEA Software package. However, the amount of new features is substantial, the most prominent being:

Integration of Microsoft InfoPath, allowing customers to design randomisation forms with a GUI, and with lots of checks and fancy form features;
Randomisation Validation Report, allowing for a comprehensive per study validation report on the randomisation setup for a trial, and the key statistical parameters to observe predictability, balance in treatment allocation and patterns in treatment allocation;
TENALEA eCRF : a full fledged eCRF system for clinical trials, with form templates built using Microsoft InfoPath which can be completed with a standard browser;
Adoption of the international CDISC ODM standard for all subject and study (meta)data;
CDISC SDTM export enabling direct transfer of data into SAS using SAS PROC CDISC;
Advanced audit trail system to help conducting a clinical trial in compliance with regulations;
Built in query system to manage the correspondence between data managers and CRA, such as validation errors, data inconsistencies and DSV requests;

The new system is made available to customers as a hosted service, or a Software-as-a-Service. To better reflect this, ALEA is renamed to TENALEA Randomisation and TENALEA eCRF. A new website will be launched 1 january 2010, and a marketing and dissemination campaign is scheduled for Q1 2010.

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