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.
The TENALEA Initial Deployment project which will be conducted in a 42 months term and started November 2006 on the basis of a comprehensive Technical Annex describing the background, workplan and management of the project. This project will be carried out by a consortium of Academic Clinical Trials Data Centres, a pharmaceutical company, a regional healthcare network and a software firm.
The starting point of the TENALEA Initial Deployment phase is an existing service for patient randomisation in clinical trials. This service 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 service is hosted in the NKI premises, and a QA system for the operational management of the service is in place. This current Initial Deployment phase is the follow up to a Market Validation phase which was completed in December 2005, and in which a business plan was developed for a roadmap towards full deployment. The businessplan concluded that a service deployment framework is required which defines the management of the services portfolio offered by TENALEA. This framework enables a controlled extension of the services offered to other requirements, such as Remote Data Entry.
TENALEA is now ready for a roll out to clinical trials data centres throughout Europe including training and education, QA and validation, compliance, localisation, local activation and migration from current systems to TENALEA for those data centers which have an existing system in place. In addition, co-location is being implemented and facilities for SLA (Service Level Agreement) based contracts will be established for service to pharma and Contract Research Organisations.
The roll out should be to a sufficient number of data centers to obtain a critical mass of Clinical Trials commissioners who use the service. Once this critical mass is reached, the service will be economic since the primary objective is not to maximise profit for the operator, but to minimise effort and cost of clinical trial data management to all stakeholders. The operational cost is shared among the data centers, while revenues from SLA based contracts are re-invested into the service and used to reduce the subscription fee of academic members.
The TENALEA Initial Deployment project will deploy three services: a randomisation service based on the ALEA service validated in the TENALEA Market Validation project, an eCRF service and a remote data entry service.
Success indicators of the project are measured through three criteria for success: 1) the number of trials which have used one or more services from the TENALEA portfolio for their operational process, 2) the number of data centres which have adopted one or more TENALEA services for one or more of the clinical trials for which they act as central data centre, and 3) the prognosis for break even operation of the service by the end of the Initial Deployment phase.
In order to monitor the project and mitigate the financial risks, success indicators have been identified for four milestones during the Initial Deployment phase, in month 12, month 24, month 36 and month 42. At each milestone, the actual achievements are compared to the planned achievements, and in case of non-compliance a go / no go decision will be made. It is anticipated that by the end of Initial Deployment 120 clinical trials will operate one or more TENALEA Services, and between 50 and 70 data centers will be using TENALEA services. Finally, the main success indicator is whether or not the service can be continued without further funding. After Initial Deployment, the service must generate sufficient revenues to cover the operating costs.