DUBLIN, Ireland - 13 Sep 2022: Deciphex announced today that the Patholytix platform now delivers the first complete GLP-compliant workflow for non-clinical safety assessment studies.
This landmark achievement will deliver significant productivity gains for organisations performing Primary and / or Peer Review as Test Facilities or Test Sites.
The Patholytix platform has been validated by Charles River Laboratories who carried out the first fully digital GLP study (Primary and Peer Review) between a Contract Research Organisation (CRO) and sponsor in May 2022. Using pathologists from other international sites, the organisation delivered a peer-reviewed pathology report approximately 1 month earlier than would have occurred with local pathologists using glass slides.
This allowed both the CRO and sponsor to meet accelerated timelines in support of the sponsor’s clinical development plan.
Shane Ryan, General Manager Research Pathology, Deciphex commented;
“Deciphex is building the world’s first secure GLP regulated network. Patholytix accelerates Safety Assessment studies, a critical success factor in the Drug Development LifeCycle, via its ergonomic Pathologist-centric workflow. We are delighted to have been able to work in partnership with the talented team at Charles River Laboratories in this trailblazing effort. Validation of the solution for regulated intended use shows the confidence our clients have in both Deciphex and the services we provide.”
"This has been a long journey starting with the work and vision of ground-breaking colleagues from Pathology, IT, QA, and Computer System Validation and our partners at Deciphex. The multi-year project included testing and qualification of the hardware, new automation initiatives for the scanning and uploading process, and the kick-off of a ‘cloud-first’ project with IT for storing/archiving digital images. The value proposition for our industry is strong. As a leading non-clinical CRO, we will be nimbler and more flexible in Pathology and can apply artificial intelligence tools that will support both quality and automation.”
Dan Rudmann, Scientific Director (Product Owner): Digital Toxicologic Pathology at Charles River Laboratories.
Deciphex is a global software company focused on developing digital pathology-based software and services for clinical and research pathology. Deciphex’ ultimate goal is to encourage widespread adoption of digital pathology for review of non-clinical GLP studies by acting as an example to regulatory agencies of its successful implementation.
Deciphex provides GLP qualified software informed by industry best practice (GAMP5) and operates an Integrated Management System focused on Information Security, Patient Safety, Data Integrity and Product Quality, certified by BSI for ISO 27001. Any customer wishing to use the software for GLP regulated intended use will be required to perform the necessary validation as dictated by their regulatory authority.
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
Deciphex and Charles River have been in a synergistic relationship since 2020. Through that partnership, Charles River became the exclusive contract research organisation distributing Patholytix, and have gone on to support around 85% of the FDA drug approvals happening every year.
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