The Biotracker™ for Biobanking solution allows your organization to collect, store, process and distribute biological materials in your BioRepository as well as associate the critical demographic data, clinical data, and biomarkers to these biospecimens. Within its BioRepository solution, Biotracker™ maintains the biospecimen genealogy with the ability to provide workflows for macromolecule DNA/RNA extractions. In general, these “biological materials” are human biospecimens – such as tissue or blood and the “Meta data” is the clinical information pertaining to the donor of that particular biospecimen. Hence, in a HIPAA compliant way, the ability to annotate biospecimens with diagnosis, stage, patient demographics, etc. is built-in.

If you are in a Medical Research Facility, the following capabilities of Biotracker™ for Biobanking apply:

• Samples arrive at your facility and Biotracker™ captures shipments from Surgery, Phlebotomy, the Floors, or Clinics as well as distribution from the BioRepository storage, based upon Principle Investigator (PI) requests per their Internal Review Board (IRB) approved protocol.
• Biotracker™ has a highly flexible Location Management hierarchy to accommodate a single Biobank or multiple Biobanks spread out across a single campus or across many sites, enabling a “Virtual BioRepository Network.”
• With a highly flexible and published Applications Programming Interface (API) layer, Biotracker™ provides interoperability with existing disparate systems so that Meta data annotation need not be manually entered, but interfaced with Electronic Medical Record (EMR), Pathology software for diagnosis, and systems which house patient demographics – all with an eye for complying with HIPAA. So, while annotation of biospecimens can be done manually, automating this task via interfaces eliminates the chance of transcription errors.
• To facilitate querying of biospecimens for disease type, demographic, etc., Biotracker™ provides a flexible Controlled Vocabulary (CV) using sources such as SNOMED, WHO or the caBIG Thesaurus. In addition, the system supports synonyms so that searches return a whole collection rather than a small subset which can happen when free text entry is allowed.
• Biotracker™ can check the IRB protocol associated with the Requestor to see if the amount of specimen and type (Fresh, Frozen, etc.) requested is approved and if Patient Health Information (PHI) is allowed.
• Tissues will be harvested with Informed Consent from surgery or a clinic while blood/serum may come from Phlebotomy, the floors or the clinic and the LIS may only associate one sample ID even though there can be 1 to many blood draws from a single patient.
  • Biotracker™ can parse an HL7 communication from the LIS and create unique IDs, which are critical for location management in a Biobank, for these “virtual” specimens.

    “Virtual” in this context meaning that the specimens are in transit.

  • Once the specimens arrive at the Biobank, Biotracker accessions the unique identifier associated with each vial and they become physically received.
  • Informed Consents are associated with the parent specimen as well as with all downstream samples so if consent is withdrawn, it is easy to locate all samples associated with that patient for removal and disposal.

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If you are in a Pharmaceutical or Biotech, the following capabilities of Biotracker™ for Biobanking apply:

• Samples arrive at your facility and Biotracker™ for Biobanking captures both requests for biospecimens as well as actual shipments to and from the BioRepository storage.
• Biotracker™ can import specimen and patient/donor information associated with clinical studies from the CRO or collaborating hospital and provides an easy way to map this data, doing so with an understanding of a Controlled Vocabulary, as each organization may have their own syntax.
• To facilitate querying of biospecimens for disease type, demographic, etc., Biotracker™ provides a flexible Controlled Vocabulary (CV) using sources such as SNOMED, WHO or the caBIG Thesaurus. In addition, the system supports synonyms so that searches return a whole collection rather than a small subset which can happen when free text entry is allowed.
• Biotracker™ has Study templates which allow the Biobank to associate the Meta data with the received specimens from a clinical trial so that Biotracker™ can become a lynchpin in Biomarker characterization, as all of the pertinent data resides in one data source

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There may be multiple specimens submitted from a single donor and each of these may be associated with multiple extractions and derivatives. Sample accessioning occurs as individual samples are created. Biotracker™ has a built-in barcode designer for 1 and 2D barcodes. As samples are subjected to processing, results/data generated need to be recorded for the samples and their progeny (daughter samples) in defined steps of a given process.

Biotracker™ manages biological materials shipped from your customers through registration of individual samples, establishment of relationships with biographic information and other samples, and recording of sample processing attributes. The samples created in the database need to be reconciled against the physical samples in inventory and released into the production pipeline.