Biobanks should be an integral part of a comprehensive research platform, not exclusively viewed as a service provider or freezer farm managed with excel sheets. For biobanks to be be viewed as a contributing partner and one that can support personalized medicine, there are a few critical components you need in your software.
Patient Centricity: Harmonization of all data from patient to protein to enable personalized medicine.
The KAIROS platform – CentraXX – utilizes a Patient Research Recordas the central storage unit. All sample information and study data collected is embedded in the PRR. This allows for a longitudinal view of data for a patient rather than isolated snapshots. In addition, other structured data from diagnosis (e.g. ICD-10), procedures (e.g. ICPM, OPS), episodes (e.g. inpatient stays), medication, consent, virtual microscopy are combined in the same file.
The pandemic has reaffirmed the need for the patient connection as we not only need to learn more about the disease but also track the long term effects. To learn more about how KAIROS is supporting Biobanking in times of COVID-19 check-out the screencast here.
Pseudonymization: The use of pseudonymized (rather than anonymized) data, which maintains the connection to the patient.
The use of anonymized data takes away the value of the research to the individual. Breaking the patient connection with the use of anonymized data eliminates the posibility of informing the patient of any results from research on their samples. It also makes it impossible to bring together longitudinal data, and datasets from more than one source and link it. No patient should be left behind and should be offered full transparency.
CentraXX was built with strong data protection in mind and is both HIPAA and GDPR compliant. Including the use of de-identification algorithms for users without access to patient data, and audit trail functionality. The added feature of pseudonymized access in CentraXX enables the recording of metadata and concrete findings in accordance with comprehensive data and patient protection protocol.
Consent Management: Biobanks are the archive of future medicine, unlocking that value starts with consent.
This requires a software tool to support a wide range of consent types and components. Consent should not only be directly tied to the patient but every sample, not merely just a signed .pdf. A biobank with comprehensive consent management in place becomes a well-rounded resource (not merely a service) to both their institution and external researchers. It also helps to build trust with patients who donate and increases the chances they will continue to participate in any recruitment activities carried out by the biobank.
Additional Information: The KAIROS biobanking module provides more than stock location management. Our sample management ensures genealogy and chain of custody with scientific and clinical operations. CentraXX’s configurable master data allows for single-point management across all your data sets to streamline interoperability. CentraXX not only handles the structured storage and management of all sample data but also establishes the context over time between these samples and all existing patient data that originate from various data sources. This creates a multidimensional image from the sum of all available data.
In addition to the Biobank module, KAIROS offers a Clinical Trial Management Solution, Metadata Repository, Raw Data Archive, Patient App., and additional dashboarding tools. To learn more, please contact us at info [@] KAIROS.US
About the Author
KAIROS GmbH & US is a market leader of data integration solutions for Biobanking and Clinical Trial Management with installations at multiple research consortia, biotech companies, and 30 of Germany's 35 university hospitals.
