Enabling Clinical Data Management with a Biobank Information Management System

October 28, 2020

What are Biobanks?

Biobanks are a repository that store biological samples obtained from humans for research purposes. Biobanks are an important part of medical research as they support research on genomics and personalized medicine.

Apart from storing and distributing the collected biospecimens, biobanks also manage donor-related information such as informed consent of donors, their medical history, lifestyle data, and demographic information.

Importance of Biobanks

1. Biobanks are important for the discovery of disease-specific biomarkers, drug discovery, and clinical and translational research. Large biobanks conduct several activities such as sample acquisition, collection, sample preparation, storage, testing, analysis, studies, distribution, etc.
2. Biobanks need to ensure patient privacy and must anonymize sensitive patient data. A biobank must ensure that biospecimens collected from patients are used for intended purposes only, and safeguard Protected Health Information (PHI).
3. Biobanks help in clinical research processes so that human diseases are better understood.
4. A biobank must ensure sample quality, right from the accessioning of samples till the time samples are present in the biobank.

Maintaining Clinical Data in Biobanking Software to Improve Clinical Research

The most important base for personalized medicine is the availability of a large collection of patient samples with annotated clinical data. Identification of biomarkers associated with medical conditions such as cancer, cardiovascular diseases, and neurological disorders helps in the timely detection and prevention of such diseases. The information should include everything from demographic data, lifestyle information to diagnosis, and treatment history. It is important to understand donors, their lifestyle choices, history, and previous diagnosis to advance research. A biobanking LIMS enables a biobank to store patient profiling data alongside the sample information. A Biobanking LIMS manages test data, quality control tests, test results, and analyzes trends across a set of samples to determine potential anomalies, thereby assuring the quality of samples. Furthermore, it can automate laboratory workflows and can integrate with analytical instruments, reducing turnaround times, and ensuring data integrity. A few of them are listed below.

1. Keeping Patient’s Profile Information While Protecting Patient Privacy
   Biobanking software allows you to record patients’ clinical and lifestyle data. Advanced security, role-based access, and field-level data encryption ensure that only authorized users can view Patient Identifiable Information (PII) such as patient name, age, date of birth. A biobanking LIMS usually has a context search functionality that enables an authorized biobank user to quickly search samples using PII. The system masks sensitive PII data to prohibit unauthorized access of confidential data.
2. Management of Patients’ Informed Consent
   It is important to ensure that biobanks have the appropriate donor informed consent as it is critical from both ethical and legal perspectives. It is convenient to track active consents and any exclusions with the enhanced informed consent management capabilities of a biobanking software.
3. Disease Profiling and Progress Tracking
   Every disease differs in terms of indicators, characteristics, risk factors, and stages. A biobanking software enables you to track each disease and its associated data markers. A biobank information management system helps create a disease profile that consists of fields to record the disease’s characteristics and stages. Additionally, it facilitates monitoring and tracking of disease progression. Biobanking software also helps create custom data-entry forms based on patients’ disease profile.

How a Biobank Information Management System Helps Overcome Clinical Data Management Challenges

There exist numerous challenges that a biobank may face. Some of them are listed below:

1. Managing biospecimens effectively
2. Locating stored samples
3. Standardizing operational workflows
4. Ensuring sample integrity
5. Preventing unauthorized access of sensitive data
6. Following biobanking regulatory guidelines and best practices, such as ISO 20387, HIPAA, EU GDPR, and ISBER Best Practices

Here a Biobanking Information Management System Comes in the Role. What does it Do?

1. Securely manage sample and patient data
2. Assign role-based access to authorized users
3. Comply with the regulatory guidelines
4. Eliminate data silos
5. Generate personalized reports
6. Reduce operational costs

It becomes easy for biobanks to manage the day-to-day operations through a biobank information management system’s dashboards where it can keep track of sample processing, laboratory inventory, number of samples stored, and staff training. The integration of laboratory instruments and software systems with a biobanking LIMS helps in data interoperability and in preserving data integrity.

Conclusion

Biobanks are now required to collect more specific and annotated data due to the emerging need for personalized medicine. For quality biobanking, it is paramount to have easy access to sample-associated data and a standardized way to record biobanking data. Patients’ clinical information is extremely valuable when the samples collected by biobanks are used for research purposes. The amount of data that can be collected varies in quantity and could be any information from personal medical history, familial history, and pathologies to treatments, etc. A good biobank information management system allows biobankers to manage a large amount of clinical data alongside sample data, with the ability to query the data in a combined way.

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