2005-04-22
European TENALEA project undergoes successful annual review
In March the European Commission reviewed and approved the continuing work of the European TENALEA (Trans European Network for clinical trials services) project, a project that since June 2004 has been looking into ways of reducing the administrative overhead in clinical trials data management.
The Netherlands Cancer Institute (Nederlands Kanker Instituut) is leading this project and in addition to five participating academic organisations and one pharmaceutical company member, InferMed is the proud commercial software project partner. The primary goal of the project is to harmonise at a European level clinical trials data management procedures, and in particular randomisation procedures, and to make available online clinical trials data management tools which follow these harmonised procedures.
InferMed’s electronic data collection software MACRO is one of the tools being made available to members of the project and this is being integrated with the ALEA randomisation software developed by the Netherlands Cancer Institute.
ALEA is a software for patient randomisation in clinical trials used either via the Internet or IVRS (Interactive Voice Response System) and supports all accepted randomisation methods and study designs. The TENALEA project will make the ALEA system available to clinical trials networks, data centres, study sites and clinicians throughout Europe and acting as the central randomisation hub for these participating groups, it will harmonise and simplify data management procedures.
The aim is to provide a European Network of trial management expertise and services with ALEA and MACRO as key software tools at its operating centre. Andrew Newbigging, InferMed’s Managing Director of Clinical Research commented, “The shift from paper-based CRFs and paper-based randomisation to eCRFs and on-line randomisation has meant that investigators are faced with a range of different systems. The aim of the TENALEA project is to harmonise and simplify systems and procedures for those that participate in clinical trials; this fits very well with the InferMed philosophy of providing robust and highly effective software solutions for clinical trials that above all are supremely user-friendly.”
About the Netherlands Cancer Institute
The Netherlands Cancer Institute (NKI) / Antoni van Leeuwenhoed hospital (NKI-AvL) (www.nki.nl) is a multidisciplinary cooperation between scientists and medical specialists. The hospital comprises 180 beds, a large radiotherapy department and outpatient clinics. Facilities for patient research include a large patient database, clinical data management, biostatistics and active research groups in epidemiology and psychosocial oncology. The laboratory covers all major areas of cancer research, with special emphasis on mouse tumor models, mouse (reverse) genetics, cell biology, immunology and translational research requiring close collaboration between clinical and basic scientists. Because of the specialised treatments in the hospital, it has acquired (as the only non-university associated hospital) an academic status in The Netherlands.
