December 17, 2020
Specifically designed for biobanks and biorepositories, a BIMS provides an ideal solution to manage and track samples. A BIMS records and manages donor information, including donor consent. It keeps records of all specimens whether in process, storage, or shipment. Along with collecting, storing, and processing specimens, it also supports ISBER Best Practices recommendations and biobanking regulatory requirements. A BIMS not only helps in the secure management of sample and patient data but also assigns role-based access to authorized users, removes data silos, and generates personalized reports.
Biorepositories are a key element in a growing number of organizations in biotechnology, pharmaceutical, and clinical research. Biobanks need to follow stringent regulatory guidelines and have data security measures in place as they contain biological samples from different sources and also sensitive patient data including their medical records and demographic information. The set-up and operation of a biobank also require legal, ethical, and safety considerations that not only pose challenges in managing the vast amounts of data collected from biosamples but also ensuring compliance with the regulatory requirements, such as HIPAA, 21 CFR Part 11, ISO 20387. Apart from this, biobanks also face numerous challenges such as managing biospecimens and patient data, tracking stored samples, automating workflows, assuring sample integrity, and following regulatory guidelines. This calls for the necessary safety framework, standardization, and harmonization of sample collection, processing, and storage protocols. Deploying a robust and configurable biospecimen management system to manage biobanking data and meet workflow automation requirements can assist biobank managers in streamlining day-to-day processes, ensuring reproducibility and traceability of workflows, and thereby preserving sample integrity.
Biobanks differ in size or capacity. Additionally, the set-up and operation of a biobank require various legal and ethical considerations. To make sure you choose the right one, we have enlisted the crucial factors to consider before deciding on a biospecimen management system. Primarily, it is best to spend some time brainstorming about the most significant issues and the pressing needs as well. The very first we could consider is,
1. Data Management & Collaboration
The essential task of any BIMS is managing samples and associated metadata. Biobanking nowadays is as much about data storage and management as it is about the storage of high-quality samples. With the increase of omics technologies and incoming samples, biobankers have observed an exponential increase in data generated per sample. Since each new technology comes with its own data processing peculiarities, it also accompanies diverse file formats. Therefore, a good BIMS must have the functionalities required for sharing different file types to address the needs of all collaborative partners. Apart from this, it is also necessary to keep in mind the personalized data management needs of your biobank. This may include getting a comprehensive or specific overview of the biobanking processes, the need to quickly trace records, or the need to collect comprehensive information on not only samples, but also patients, questionnaires, or protocols.
2. Scaling Options
Once a streamlined data flow is ensured, it is important to consider what scaling options does the software offer. Many times biobanks exist in organizations that also conduct clinical trials or pre-clinical research. In such cases, the data management process is more challenging since it involves the harmonization of data types from multiple sources to setting up and automating necessary workflows to streamline various processes. Hence, it becomes necessary to ensure if your biobanking software meets the complex and diverse data management needs of your biobank. A biobanking LIMS must also have the option to add or remove users when you scale your operations. It is best to choose a system that could be upgraded seamlessly according to the requirements of your biobank.
3. Data Integrity Features
In a biobank, the sample data commonly change over time. To track sample data changes, a BIMS must be able to capture and record every change made by all users to every sample record with a date and time stamp. A biobank must retain a history of its sample data changes to support data accuracy.
A biospecimen management system functions more effectively when it is integrated with other systems and applications in a biobank. Instrument and software integration facilitates data interoperability between different systems, eliminates data redundancy, and automates workflows. It also improves the data quality and integrity by eliminating transcription errors. It saves a lot of time as every process is automated. A BIMS must be integrated with software such as Laboratory Information System (LIS), Electronic Medical Records (EMR), temperature monitoring systems for smooth management of samples and associated data.
Before zeroing in on a biobank management software, it is worth considering the opinion of all users. An effective BIMS should be easy to learn and intuitive to navigate, accessible to users outside the organization for easy collaboration, and have the functionality to assign different role groups with varying permissions and restrictions. Each biobank should map out all potential users who could be lab technicians, coordinators, lab managers, and evaluate if a BIMS can meet the distinct requirements of all users. A correctly chosen BIMS ensures maximal efficiency at all stages of the biobanking processes by aligning with users’ convenience and requirements.
5. Privacy, Security, and Compatibility
In addition to serving research needs, biobanks also need to comply with necessary regulatory requirements such as HIPAA, ISO 20387, EU GDPR, and others. Patient privacy is of utmost importance for biobanks as they not only store sample data but also maintain donor data. Hence, it is crucial to choose a biospecimen management system that allows the sharing of information with researchers intending to use the samples for research without compromising data security and privacy. Although patient privacy must be maintained but not at the expense of limiting sample availability. A good BIMS should therefore address confidentiality issues while ensuring a secure chain of custody and efficient data sharing among collaborating research institutions.
6. Research and Networking
Current research practices frequently involve collaboration with contract research organizations (CROs). Biobanks and biorepositories need to make sure that they provide high-quality services to these organizations in a cost-effective manner. Deploying a unified system also smoothens the flow of information and communication. Furthermore, a system can be configured to meet the evolving demands and enable efficient data transmission in addition to ensuring procedural compliance.
Choosing a BIMS for sample management at your biobank could be a complex and time-consuming process. Although there may be features that may not contribute much value, certain key features are essential when it comes to choosing a biobanking LIMS software. An effective BIMS should be configurable according to your specific needs so that it can capture any data elements and data fields related to your samples. It should be able to record the precise location of every sample in your biobank. Biobanks usually have numerous samples and hence a good BIMS should enable you to create and batch update a considerable number of sample records. A biospecimen management system should maintain a record of the history of every sample information, be it freeze-thaw cycle count, processing details, or storage location. This functionality is also essential to meet regulatory requirements. A BIMS should enable you to search and filter through samples to retrieve specific sample records, allowing you to easily and quickly respond to requests for specific samples. These crucial factors must be considered while selecting the right BIMS.