CentraXX in Action: Going Live at Finch Therapeutics
Finch Therapeutics is a groundbreaking biotech company at the forefront of research and development of microbiome-based therapies. Using stool from healthy donors, Finch develops therapies to combat a range of diseases such as C. difficile infections and Inflammatory Bowel Disease (IBD).
Recognizing the need for a specialized software solution that would help manage its donor operations, product manufacturing, and biobanking processes, Finch issued an RFP in October of 2017. Finch’s request consisted of two main components: (1) management of all processes involving donors, from initial enrollment to retirement (2) oversight and operation of the complete biomanufacturing process, from receiving and processing the donation in the lab to shipment and delivery of the product to requesting partners. Finch was looking for a vendor that offers configurable tools off-the-shelf to meet their wide-ranging and highly specialized requirements and that provides qualified operation support.
For Kairos, the opportune moment to put it all into practice
The implementation of CentraXX at Finch presents the unique and exciting opportunity for Kairos to bring many of the software tools it has developed together into one comprehensive solution. Finch will use CentraXX not only to track biospecimen and facilitate biomanufacturing processes according to GMP, but also to guarantee that all data on donors and their samples are interlinked. This feature creates huge potential for Finch, as all information received on donors at any point can be applied to evaluate the potential impact of a product derived from their sample. For Finch, using CentraXX also means significantly reducing the number of software systems currently in place. This ultimately streamlines processes, raises data quality, upholds data protection rules, and makes clinical decisions more transparent and traceable.
Responding to Finch’s RFP, Kairos prevailed against a total of twelve American and international competitors. Kairos’ ability to offer a comprehensive tool set that brings together a biobank management system, a raw data archive, a clinical trial management system, and a patient/donor APP into one software solution set it well apart from competitors. More than satisfying Finch’s original criteria, CentraXX also stood out in its ability to integrate its robust de-identification apparatus, allowing Finch to adhere to strict data protection regulations such as the GDPR. Another deciding factor that set CentraXX apart was the ability to efficiently validate the software, a process supported by the ‘Kairos Validation Kit’.
What it looks like to work with Kairos
The journey with Finch started in January 2018, when Kairos and Finch began collaborating to build out Finch’s biomanufacturing processes and donor operations into their customized CentraXX system. The first few months were spent jointly outlining and molding Finch’s processes into the CentraXX software. Next, eCRF (electronic case report forms) and measurement profile templates were created for documenting donor information and interactions between donors and Finch. After building these specifications into the software, Kairos launched the first of two training periods for members of Finch’s Donor Operations. First in August and again in October, Kairos representatives trained Finch staff on the system layout and the use of the CentraXX software. Throughout this process, Finch’s new system underwent validation, which Kairos supported by offering its Validation Kit to expedite the process. This included, among other things, an automated UI test-suite, a 21 CFR Part 11 Compliance statement, a GxP Impact assessment, configuration specifications, a Risk Management Report, IQ/OQ protocols, and an on-site customer audit. Following validation and two successful training periods, CentraXX officially went live at Finch. As of October 9th, 2018, Finch has been successfully documenting all donor-related information in CentraXX.
A look at the final product: Finch’s very own CentraXX
In the end, Finch had in place a highly specialized and thoroughly secure system for managing their complex donor operations. Every operation, communication, event, or measurement finding related to a donor is captured in a central database in direct association to the donor. Finch also now has an extensive reporting tool integrated to CentraXX at its disposal, for generating operational and validated reports from captured data, which plays a central role in managing donors and running routine operations. Lastly, Finch is also putting the CentraXX XML Interface to use, which supports the importing of legacy data and the exporting of all relevant donor information, allowing the system to network and interface with external data and other software. Kairos is currently also establishing an HL7-based interface that will allow ordering and receiving lab tests directly from and into CentraXX, linking structured findings to the specific samples that were screened. The wide-ranging capabilities of CentraXX’ extensive software tools came together in a unique way that was vital for the successful implementation at Finch.
“CentraXX has revolutionized the way our donor data is captured and managed. Data is now documented in a consolidated, structured, and reportable environment. CentraXX has been a huge value add for Finch, and I am looking forwards to how we can find new applications for the CentraXX software for our other processes.”
-Finch Therapeutics Project Manager, Samantha Kitchen
This is just the beginning…
Kairos’ partnership with Finch has only just begun. Looking to extend their new streamlined processes and structured data capture to its biobanking department, Finch has already begun drafting specifications for adding CentraXX Bio to its software toolset.
After adding this piece to donor management, every Finch biospecimen and its associated data will be stored and managed using the CentraXX biobanking module. Ensuring the link between donor and stool donation means that each piece of data is fully contextualized. This structured and centralized mode of data storage also makes the data more readily and easily accessible, reducing the time that is currently spent searching across separate databases.
“We at Kairos see Finch as a perfect match with Kairos. Finch’s future with CentraXX could become expansive, as a wide range of complimentary tools by Kairos still exist that can help to continuously turn CentraXX at Finch into a vital component of its operations. We have now successfully implemented the donor management system at Finch, but the future includes much more, such as an extensive biobank management system, a raw data archive, a Clinical Trial Management System, and even the CentraXX PatientApp to draw donors and patients even more into the processes. Planning for the second stage of the project has begun and we are looking forward to future collaboration.”
-KAIROS CEO, Martin Zuenkeler
Kairos has much more to offer, making future collaboration between Finch and Kairos more than likely. For one, CentraXX’ integrated Workflow Engine provides the possibility to mold specific biomanufacturing processes into system-driven documentation sequences according to GCP. Kairos also offers the CentraXX Patient App, which could be used to involve donors as well as patients more closely within the program while improving communication and data collection. The Raw Data Archive could also be added, which could be used for storing large amounts of associated data (e.g., genomic data and photos). Kairos is looking forward to what the future collaboration between Kairos and Finch brings! Stay tuned!