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The OnkoDataMed GmbH (ODM) was founded in 2003 to design, program and operate a system for documentation and quality assurance for practicing oncologists.
This resulted the certified system ODM QuaSi which is now considered as standard documentation in the established Uro-oncology and gynecologic oncology.
Further professional disciplines are in progress.
ODM QuaSi is recognized as quality assurance system by physicians, professional associations and scientifical oriented pharmaceutical industry.
The existing anonymous data sets are the basis of retrospective studies and questions of market research. Since the ODM offers all for the conduct of non-interventional studies (NIS) necessary services, it is also known as CRO in great demand. In medical and scientific circles, the ODM has become known through participation in studies of health services research.
Due to the information assets of the oncological care reality ODM is also a sought-after interlocutor of the health insurance provider.
The quality of all ODM-products and services is defined and capturched by SOPs (Standard Operating Procedures) which consider the following regulations:
- International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline of Good Clinical Practice (GCP)
- Drug Law (AMG)
- Common recommondations of BfArM for AWBs
- DIN EN ISO 9001:2008
- Declaration of Helsinki
Compliance with the requirements is monitored by regular internal and external audits.