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Core Informatics Launches Validated Cloud Platform to Provide Alternative for Regulated Labs

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NEW YORK (GenomeWeb) – Core Informatics recently launched a validated version of its cloud-based Platform for Science infrastructure that targets regulated laboratories in the biopharmaceutical industry and clinical genomics. 

Core's Platform-for-Science system offers access to the company's laboratory information management system, electronic laboratory notebook, scientific data management system, and collaborations products. It also provides access to commercial preconfigured scientific applications that the company has developed for biobanking, next-generation sequencing, quality control, and analysis.

The new offering uses validated cloud infrastructure from Amazon and Core has completed all necessary installation, operational, and performance qualification protocols and procedures to satisfy Good Laboratory, Clinical, and Manufacturing Practices guidelines, Kevin Cronin, Core's chief commercial officer, told GenomeWeb.

"It's all geared, at a very high level, to making sure that the data that is entered electronically is just as secure as data that you would have written down on a piece of paper," Cronin said. This means, among other things, that Core documents all software code as it is written and track all changes that its developers make to the underlying code. Furthermore, when customers operating in the validated environment need more compute capacity, Amazon will ensure that their workloads are passed on only to validated servers rather than to the closest available servers. Customers of the platform do still have to validate their workflows independently but they can then run those validated workflows on the Core cloud, Cronin said. The company provides scripts that help customers complete the installation and operational qualifications for their workflows.

Core has historically offered both an on-premise and a cloud-based iteration of its platform. Regulated labs have traditionally opted for the on-premise version of the software that they validate internally to support their laboratory activities, Cronin said. Using a validated version on the cloud, customers who have till now relied on local infrastructure can now reap the benefits of low IT overhead, scalability, reduced deployment timelines, and lower infrastructure costs that cloud environments provide, he added.

Core will continue to offer the existing non-validated version of its Platform-for-Science. Both solutions offer the same tools but the validated version is configured differently to meet the regulatory requirements and needs much greater attention to detail, including meticulous documentation of changes made to workflows, than the non-validated cloud offering.

Existing customers of the Platform-for-Science include Biogen, Mount Sinai Hospital, and Thermo Fisher Scientific, who use the solution to handle NGS workflows and data in their laboratories. In addition to using existing applications available in the platform, customers can also implement their own NGS workflows, as well as workflows for NGS-adjacent research activities such as immunohistochemistry experiments, flow cytometry, pathology, and biobanking.

Cronin expects the validated solution to appeal to hospitals and clinical laboratories, biopharmaceutical companies, as well as test and reagent kits developers. In addition to drawing in new customers, the validated offering could boost the platform's use among existing customers. For example, a biopharmaceutical company that already uses the non-validated cloud option for its research could adopt the validated product for use in clinical testing, he said.

Furthermore, "One of the major factors why people [previously] chose to [install the software] on premise was because they couldn't validate on our cloud environment," Cronin said. Moving forward, "we think that more and more will be on the cloud" but "it's hard to say because some customers are very risk averse and they still think on premise is safer than the cloud."

One factor that could sway some of those clients are the cost savings that accrue from running software solutions on the cloud, which Core says are significant. "One key element of validation is that [customers need] extreme levels of backup, which means extra servers that you have to pay for and maintain if you do it on premise," Cronin noted. With Core's validated cloud product, Amazon provides those servers on demand for a fraction of the costs of purchasing, installing, and maintaining servers in house. According to Amazon's estimates, customers who use the validated Core platform on AWS can expect cost savings of up to 80 percent.

Like for the non-validated version of Platform-for-Science, the company will charge an annual subscription fee. The validated offering is more expensive than the non-validated option because there is more due diligence required but it is still much less expensive than trying to maintain the same solution on site, Cronin said, adding that the company does not disclose pricing information.

Moving forward, Core hopes to build an ecosystem of partners to create and provide applications that support biopharma and genomics research. The company already has partnerships with ChemAxon, Biomatters, Certara, and Affymetrix. It is currently finalizing a deal with at least one unnamed bioinformatics company and is working on additional collaborations with other genomic data analysis companies, Cronin said.

Meanwhile, the company is continuing to grow its marketplace of commercial applications. "We have put together workflows to support NGS for the Illumina workflow and for the Ion torrent workflow," Cronin said. "Those have driven not only a lot of interest but have really made it easier for us to deploy new applications for new customers." The company has also released new solutions for handling biologics. These apps provide capabilities that help scientists to register biological samples and to perform high-throughput sequencing, as well as to track and manage sample data and lineage across experiments and locations. The company has also added apps for managing animal health facilities, Cronin said.

Last month, Core launched version 5.2 of its platform, which includes a new application programming interface that uses the Open Data Protocol (OData) standard. The OData API will make it easier for the company to integrate its platform with other products that use the same standard, Cronin said. The company is now gearing up for the next major release of its software but did not provide details or a timeline.

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