Biobanking requires intelligent controlling
in the direction of: personalized medicine

So far, documentation often remains a snapshot, which focuses solely on the time of extraction. Our research portal however places all relevant data together continually, and combines them sensibly in the context of their development. More and deeper-reaching conclusions can thus be made.

CentraXX not only handles the structured saving and management of all data regarding tissue samples, but also sheds light on the context between all samples and the available patient data. Information from other research projects can also be added. This turns the available data into a three-dimensional representation, a vivid image; snapshots become longitudinal documentation, in which highly complex data is managed and contexts can be shown.

Access with de-identified patient data allows for the inclusion of organizational information and concrete findings in accordance with data- and patient protection. The module Biobanking provides all functions needed for showing a sample’s history. This means that the process does not begin with the actual lab work, but from the time of patient registration. CentraXX provides its tools while complying with data protection rules, such as informed consent and further disease information.

Phase I: Sample Extraction

The first step is identification of, and consent by the test persons or patients. CentraXX helps with an extensive research mechanism and makes the deposit of declarations of consent very simple. A decisive advantage is the integration of digital signatures or ‘digital pen’ solutions. The consent given by the test persons/patients can be reviewed by authorized users at any time.

Informed Consent Management is a necessary precondition for the permission to carry out research for humans. Consent must have been given and must be documented in order to be allowed to gain new findings with the data or the patient’s physical samples or through trial participation. Knowledge gained these ways has always been the foundation for further development and revelations in medicine. Realizing the goal of personalized medicine will be furthered through intelligent data integration. Implied consent can no longer be built upon alone. Informing patients, while communicating almost like between partners, will be helpful to enable long-term use of the material and resulting analysis data.

Phase II: Initial Asservation

Extracted biospecimens must be stored in compliance with minimum standards such as SPREC. CentraXX assists by integrating necessary catalogues as well as a controlling tool that is based on a workflow-engine fully integrated in the system. This means that SOPs are not only documented as a static blueprint, but rather that the system can flexibly adapt to the customer’s individual procedures, and convert them into flexible and dynamic system workflows. Individualized task lists are generated. Transparency is raised.

Phase III: Reproduction

A modern biobank needs to be armed for high-throughput. Hence the documentation of entire sample packages, and not only of individual samples, becomes relevant. The newest barcode scanners can be put to use to this end. Aliquot-machines can also be connected to CentraXX via interfaces.

Phase IV: Processing

Changes to the initial biomaterial are registered by CentraXX and documented automatically depending on the devices that are used. Results that were made through sample and aliquot analyses are reinserted into the biobank-system using the integrated measurement data module.

Phase V: Reporting

The integrated reporting tool enables any significant ad-hoc inquiry and independently maintains inventories. This makes it possible for you to call up ‘account statements’ for your biobank any time and forward them to partners. Furthermore, CentraXX grants partners access to the reporting tool, similar to how online banking functions. The analyses of a biobank become especially interesting under statistical considerations. CentraXX can provide templates for commonly used statistics programs. A standardized export via CSV is also possible.

Phase VI: Sharing

This is where we face one of the biggest challenges in modern biobanking. A biobank can only then be pointed towards knowledge advancement, if samples can be provided for research. CentraXX can assist a researcher’s accreditation with a workflow. Only accredited researchers may run queries in the system and receive results. Once a researcher comes across a sample that appears relevant, a reservation order can be placed. Searches and reservations can be made in a tailored self-service portal. He does not have to contact a biobank-hotline that is responsible for these processes, but can rather become active himself. Searches that were run by the researcher and orders that were placed can automatically be provided to the board or to the sample administrator directly.

Once the necessary decision for rendering the sample has been made by the sample and data owners, the sample can be prepared for shipping. The researcher can always login to the portal in order to check the status of his order. It becomes possible for researchers to reenter any or all information derived from sample analysis, of course only to the degree to which he is willing to share his research and in accordance to the type of consent provided by the donor. Always interesting is the information of how much of the sample material the researcher has left over. This can be managed by CentraXX with its capability of running inventory management for decentralized or centralized storage structures.