Case Study: OpenBiome
“Using CentraXX reduced the number of software systems in place, streamlined our processes, and improved data quality,” said Carolyn Edelstein, Executive Director of OpenBiome. “The end result is full transparency into our stool banking operations and improved care for patients in need.”
About: OpenBiome is the first public stool bank, and a 501(c)3 nonprofit organization, founded to expand safe access to fecal transplantation for patients with recurrent C. difficile infections and to catalyze research on the microbiome’s role in human health. OpenBiome provides clinicians with rigorously screened, ready-to-use fecal microbiota preparations and supports researchers with a suite of tools to discover how gut bacteria might treat diseases beyond C. difficile. Since 2013, OpenBiome has partnered with over 1,200 healthcare institutions across all 50 states to deliver more than 55,000 treatments for recurrent C. difficile. Its research portfolio includes 36% of all active and completed trials in the United States exploring the use of fecal transplants to treat a wide range of indications including autoimmune disorders, mental health disorders, and malnutrition. For more information, visit https://www.openbiome.org.
The Need: OpenBiome recognized the need for a specialized software solution that could manage its donor operations, product manufacturing, and biobanking processes. The solution needed to (1) manage all processes involving donors, from initial enrollment to retirement and (2) have oversight and operation of the complete bio-manufacturing process, from receiving and processing the donation in the lab to shipment and delivery of the product. They needed a vendor who offered configurable tools off-the-shelf to meet their wide-ranging and highly specialized requirements.
The Solution: KAIROS’ solution CentraXX offered a comprehensive toolset that manages donor relations, seamlessly tracks biospecimens and resulting products, and offers customized workflows to map OpenBiome’s standard operating procedures. The initial implementation was completed in two stages with the aim to continue to build out the system as needed, for example, developing an interface to a large diagnostics provider.
The first stage of the project involved setting up OpenBiome’s donor operations. Electronic case report forms (eCRF) and measurement profile templates were created for documenting donor information and interactions to support their continuous re-qualification and quarantine procedures. CentraXX also provides donors access to the system so they can complete health surveys as needed.
The next stage of the project involved setting up their sample management and building several workflows to support their processes. The system tracks measurement findings and location of initial donations, aliquots, and resulting treatments. All aliquots and products remain tied to the initial donation as well as the donor. Customized workflows were built to meet OpenBiome’s specific needs and processes including donation receipt, screening, processing, and shipping.
During implementation KAIROS conducted user trainings and validation which included automated UI test-suite, 21 CFR Part 11 compliance statement, GxP impact assessment, IQ/OQ protocols, and an on-site customer audit.