TENALEA
C# - .NET DEVELOPMENT - STATISTICAL ANALYSIS
TENALEA is an initiative of a consortium of European Acadamic clinical trial data centers and a pharmaceutical company. The main objective of TENALEA is to reduce administrative overhead in clinical trials data management to the investigator, data centers and stakeholders. The key instrument to achieve this objective is harmonisation of the Clinical Trials Data Management tools which are being pushed towards the investigators and study sites. TENALEA is an initiative to provide best-of-breed solutions for a cost price to those who are now faced with major development costs, operational and support costs, and costs for QA and compliance. Currently, TENALEA provides a comprehensive randomisation service which supports all methods used in clinical research today. In 2008, the service portfolio will be extended to include RDE – Remote Data Entry, and eCRF – electronic Case Report Forms.
ADL Consulting were asked to provide validation of the TENALEA randomisation methods. Since September 2007, we have been working closely with the TENALEA staff to develop the testing methodology, algorithms, and deliverables. Currently, a series of twenty two (22) graphical results are produced, providing results of analysing the test data in multiple different dimensions.
Further information on TENALEA can be found on their website, http://pl.tenalea.net/default.aspx