About the Innovator
The department of Paediatric Oncology and Haematology of Saarland University is the centre for treating children with cancer in the State of Saarland and the surrounding area including Luxembourg. 95% of children with cancer are treated within clinical trials. The Head of the Department is chairing the Renal Tumour Study Group of the International Society of Paediatric Oncology. The department participates in EU funded projects bringing together clinicians, basic scientists, lawyers and IT to pave the way to personalized medicine.
What is the innovation
ObTiMA is an ontology-based and GCP compliant CTMS intended to support clinicians in designing and conducting clinical trials. The design phase is facilitated by a graphical trial builder where all clinical trial aspects and CRFs can be specified. The patient data management part is automatically set up based on these definitions and handles all patient data securely by e.g. using a complex role-based access system. The technology’s maturity is at Technology Readiness Level 7 (System prototype demonstration in an operational environment).
Out of the lab- Into the Market
To bring the innovation out of the lab, the following steps will be undertaken: ObTiMA is now running in an operational environment with one international trial group for kidney cancer, called SIOP-RTSG. In 2017 ObTiMA will be advertised to other academic trial groups within Paediatric Oncology followed by adult trial groups in Germany in 2018 for running ‘Investigator Initiated Trials’. Before going to the market and addressing the pharmaceutical industry, the system will be certified starting in 2018.
Benefits of participation in the Framework Programme
The participation in the Framework Programmes has enabled the development of ObTiMA to its current stage. The development of a CTMS requires close collaboration of experts from various disciplines, i.e. IT and legal experts as well as clinicians, which could not have been achieved without the EU projects. ObTiMA is the result of several projects carried out under the 6th and 7th Framework Programmes, including the large-scale projects ACGT and p-medicine.