SOLUTIONS

BIGR®

GulfStream Bioinformatics' flagship product, BIGR® (Biomaterials and Information for Genomics Research), facilitates the collection and management of large, diverse and distributed repositories of biomaterials. Based on years of experience in sample collection, processing and repository management, BIGR® 5.0 consists of a suite of web-based software, standard operating procedures (SOPs), deployment and training materials and supporting services.

Since 2001, the BIGR® System has been used to:

  • Manage more than 200,000 samples collected at multiple biobanking sites
  • Support enrollment and consent of more than 18,000 donors and collection of associated clinical data
  • Track donor and sample status, history and chain-of-custody events
  • Identify appropriate material for specific research needs, including molecular and tissue-based derivatives
  • Distribute samples and data to more than 60 leading medical institutions, biotech and pharmaceutical companies

BIGR® Fact Sheet

The BIGR® System Modules

Inventory, Logistics, Tracking and Distribution System (ILTDS) is an integrated logistics system that supports the entire biospecimen banking process. Donors are assigned numerical IDs, associated with IRB-approved protocols and informed consent interviews, and tracked through diagnostic and surgical procedures. Samples are bar-coded at the point of banking and logged into the system immediately. Cases and samples are assigned to Inventory groups based upon multiple criteria, providing secure restricted access to samples within the system. Locations, users, and status are tracked as samples move throughout the system, and an audit trail is maintained.

The Sample Registration module enables the quick and efficient entry of samples and their attributes in a flexible and configurable manner. Samples may be bar-coded at the point of banking and logged into the system immediately, or they may be registered upon arrival at a storage location.

The Derivative Operations module enables the user to subdivide, aliquot, pool, and perform other derivative processes, while maintaining sample genealogy.

The Inventory Control Panel (ICP) displays the history of repository elements and tracks status changes and events. This provides the project manager, repository manager, researcher, and laboratory technician valuable context and history, including a chain-of-custody report with specific details on each of the tracked activities.

The BIGR® Library Access module, designed by scientists and researchers from diverse disciplines, is a powerful query tool to locate and compare biomaterials. Users browse through a large set of structured fields describing donor demographics, diagnoses, and/or sample findings and formats to identify materials of interest. This module integrates with ILTDS, allowing researchers to request that samples be delivered from the repository to their labs.

The Donor Data Collection (DDC) module enables collection, management and querying of both structured and unstructured clinical data. A set of web-deployed electronic Case Report Forms (eCRFs) provides the front-end tools and standards-based controlled vocabulary to capture data specific to patient demography, diagnoses, and surgical pathology.

KnowledgeCapture is a powerful information modeling and data capture technology that provides software and supporting services to structure and standardize data collection efforts across an enterprise. Methodology and technology have been developed to expedite the incorporation of new clinical elements into the data model, enabling the rapid deployment of additional data capture capabilities. Dynamically generated user interfaces, complex data models, and XML interfaces are constructed using this toolkit to capture rich, categorized, configurable data.

The Pathology Verification module enables the quality control and annotation of individual samples, with complete support for histology and pathology workflow protocols. Given the heterogeneous nature of biospecimens, each sample requires individual analysis to determine its specific characteristics. Pathologists are guided through a set of protocols to capture structured sample-specific information such as cellular composition and representative digital images.