Regulatory Assistance

Regulatory approval

Regulatory approval and quality assurance demands are stricter than ever and it is well known that solid scientific documentation will no doubt have an important impact on these processes.

With the huge number of donors, HUNT is able to provide top level scientific data and documentation for new indications on existing drugs. As part of this, HUNT can also offer clinical intervention studies on very well characterized donor groups making the biobank a unique resource in the planning of such studies. This will also have great impact on the regulatory approval of new indications.

The HUNT biobank is certified according to the ISO9001:2008 Quality Standard and HUNT Biosciences is the only company or institute that can grant access to the biobank.

Access to other registries

The value of gaining access to other registries is tremendous since it is possible to follow a great number of relevant co-morbidities over time. Every patient included in the HUNT registry is identified by the unique PIN used in every Norwegian registry. It includes every health record, social record, family record, work record, criminal record, etc. Pending approval from the ethics committee, we are able to link every HUNT Diabetes case with the Norwegian registries.

It is possible for HUNT to identify donor groups and match controls using clinical end-points registries in linkage studies. Linkage studies are of great importance as diabetes has several known co-morbidities noted in the linkable registries. This includes cardiovascular diseases, anxiety, depression, musculoskeletal diseases, and various cancer diseases. Each HUNT donor group can be matched on the use of various medications using the prescription registries as well as links to family members, covering inherited diseases and conditions. Other important registries are the cancer and cause-of-death registries, as well as 40-50 other national quality registries and the Social services registries collected by GPs.

Together with the HUNT information, this constitutes an unprecedented resource in terms of both data and biological material available for clients studying diabetes or developing diabetes-related products. Using this recourse to develop therapeutic and diagnostic products is expected to have great future impact on the development of diabetes. In addition, using supercomputers with complex system biological modulations, it is expected that the HUNT data will be groundbreaking in the emerging highly computed development of new products.