Poster Presentation Biobanking - Blue Sky Horizons (ABNA 19th Annual Conference)

Biobank Data Management - Multiple Challenges, One Solution (#35)

Shonali Paul 1 , Mrinal Kanti Chatterjee 1
  1. CloudLIMS Lab Solutions (India) Pvt. Ltd, Indore, MP, India

Biobanks store biological samples for research purposes and maintain all associated data. They perform several activities such as sample acquisition, collection, sample preparation, storage, testing, analysis, and distribution. Biobanks are important for the discovery of disease-specific biomarkers, support drug discovery, clinical research, and precision medicine. For this, they need to manage sample-donor information, such as donors' medical history, informed consent, and demographic information. They also need to ensure that donor samples are used for intended purposes only by maintaining quality. It is essential to ensure donor privacy and hence safeguard the Protected Health Information (PHI) of donors.

Biobanks face numerous operational and regulatory challenges, such as managing biospecimens, associated metadata, and donor consent, locating stored samples, standardizing operational workflows, ensuring sample integrity, safeguarding sensitive data, bridging data silos, and following regulatory guidelines such as ISO 20387, HIPAA, EU GDPR, 21 CFR Part 11, and audit trail. Automation and informatics solutions, such as a LIMS, helps assure the quality of samples by determining potential anomalies. It helps minimize the operational costs of biorepositories and ensures data integrity and security.

Some of the benefits of deploying a LIMS are below:

  • Manages and securely stores donor data by providing role-based data access to authorized users.
  • Manages and tracks active informed consent of donors to meet ethical & legal perspectives.
  • Manages documents, such as Standard Operating Procedures (SOPs), and tracks their revision history.
  • Manages all biobanking equipment and schedules timely maintenance and calibration.
  • Maintains a complete chain of custody to regulate the internal or external transfer of biospecimens from one custodian to another.
  • Manages, tracks, and records staff training.

A good LIMS helps manage the complete data of biobanks and ensures its integrity and security. A LIMS can help automate workflows and reduce the operational costs of biobanks.