Indivumed Achieves ISO-9001:2008 Certification and Offers the First Certified Biobank in the World
News Apr 27, 2010
Hamburg-based Indivumed GmbH today has achieved ISO-9001:2008 certification. The company, which offers biobank products, clinical data and research services for the development of personalized cancer therapies, is now the world's first ISO-certified provider of human biospecimens.
“We are very pleased with the certification," said Hartmut Juhl, CEO of Indivumed. "It proves our extremely high standards in quality management and strengthens our leading position in the field of biobanks and related services. We have already set the gold standard in this field and this is another important quality seal for our solutions."
The certification guarantees that all processes at Indivumed are fully controlled and documented. Thereby, customers can expect identical quality levels for all tissues and other biospecimens, regardless of when and where they have been sampled. In addition, it proves that Indivumed's preclinical and clinical services, the identification of drug targets and biomarkers, and drug profiling are subject to strict quality management.
"This is a very important prerequisite for cancer drug and biomarker development in clinical trials which require a particular high level of quality control by regulatory agencies such as the FDA," Juhl added. "Now, our customers can use our tissue, data and services to develop personalized cancer treatments in clinical trials, e.g. for the development of companion diagnostics to guide targeted therapeutics."
For the certification, Indivumed has established a quality management system to cover all processes and developed standard operating procedures including robust control mechanisms. "The key challenge has been to standardize processes and procedures while at the same time ensuring the necessary speed and flexibility," said Juhl. "As we are in full control of every step in the sampling of tissue and data, we are in the unique position to enable such high quality standards."