Case Study

Managing Biospecimens & Biorepositories With OnCore

Source: Forte Research Systems, Inc.

In the context of clinical research centers, the nature of biospecimen management is considerably more complex than the prospective banking of discarded tissues. There are several additional requirements and challenges. These include accommodating access to biorepository inventories and associated clinical and analytical data by a large organization of people while protecting the donor privacy and complying with HIPAA regulations. Additionally, the quality of each specimen, as well as the quality of the data linked to it, throughout the lifecycle of the specimen and all of its derivatives, must be assured.

Leveraging Forte Research System’s experience and the clinical research management functionality in OnCore, the OnCore biospecimen managment system supports all aspects of biospecimen and biorepository management from scheduling, collection and annotation, through specimen processing, storage, quality  assurance and requisition to withdrawal, distribution, and depletion. It is a web-based system that includes support for workflow, specimen-centric data storage, and access controls based on patient consent and researcher intent. It is architected to support logically centralized but physically distributed specimen collection and banking, it is fully integrated with the clinical research management application, and it supports both prospective banking as well as correlative studies.

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