This service will provide CRO, pharmaceutical, and biotechnology companies with an effective solution to engage with specialist veterinary pathologists from anywhere in the world to review digital studies, while conversely allowing the consultant to efficiently onboard and review non-clinical studies, from any partner.
Deciphex’s ‘Enabling Consultants’ service encourages the adoption of digital study review. Until now, a standard animal study would have to be sent via a number of shipments. Valuable time is wasted waiting on the arrival of the study content before any review can be begun, and this is even before the slow, laborious process of unpacking and checking the slides before review. Slides must then be returned to the sender location either by air or shipment which is both uneconomical and environmentally unfriendly.
Shipping animal tissues from country to country is a stringently regulated operation that requires detailed, and often confusing, document submission processes. This is specifically true for non-human primate (NHP) studies. Often studies can remain in customs for extended periods of time, due to lack of correct documentation submitted with the shipment, or documentation errors. This can delay the peer review process by weeks or even months, having a negative impact on the speed of the drug development process.
With Patholytix Preclinical, studies can be accessed directly by pathologists, allowing the study review process to occur in an ergonomic manner and begin comparatively quickly. Our solution improves workflow and accelerates study review for consultant pathologists and CRO/Pharma alike. The service is quicker and more cost effective than shipping slides or travelling to partner sites, while also having a lower carbon footprint. There is also reduced impact on slide import/export regulations, such as CITES for NHP studies, a common pain point for pathologists and their partners when shipping studies.
Through Patholytix Preclinical, the service guarantees best-in-class workflow supporting efficient review of both GLP* & Non-GLP studies, while also improving accessibility for both the consultant and their partners. Consultant pathologists can receive studies from anywhere in the world and easily access them through the Patholytix Preclinical platform, and the study sponsor can share studies with any specialist consultant of their choosing to review.
Deciphex’s new service benefits both small and large Pharma and Biotech companies. For smaller companies that do not have the bandwidth internally to carry out primary or peer review of non-clinical toxicology studies, Deciphex provides access to enabled pathologists to carry out these reviews. For larger companies that have the capacity to perform study reviews internally, the reason for consultant pathologist outsourcing may be a requirement for access to subspeciality consultants not available in house. Not only this, but pathology consultant services may be necessary in situations where a study must be performed within a GLP-validated* setting. In all these circumstances, Deciphex’s consultant service overcomes these issues, streamlining the Peer and Primary study review process.
The service is provided on a fee per study basis with cost charged to the referring organisation requesting the study review to be carried out. Deciphex will furnish consultants with a complete solution to facilitate onboarding of studies from any Pharma, Biotech, or CRO partner using our Patholytix Preclinical platform, with no direct cost to the consultant. Studies are easily shared with the consultant pathologist via the Patholytix Preclinical platform. This study can then be accessed by the consultant via the Patholytix Preclinical Study Browser, allowing them to begin their review process immediately in the same ergonomic workflow used by many of the Top 10 global Pharmaceutical companies.
Commenting on the ‘Enabling Consultants’ service, pathologist Sarah Taplin from Integrated Biologix GmbH says:
“The Patholytix digital pathology system has the potential to address some of the challenges faced by consultants when reviewing histopathology data from toxicology studies by eliminating issues associated with the transportation of glass slides and also facilitate an efficient integrated review and interpretation of the histopathology data through access to all the other study data on the same platform.”
If you are a CRO, Pharma or Biotech company interested in accessing specialist preclinical consultant pathology services, or a consultant interested in becoming enabled to onboard studies digitally from any of your partners please contact firstname.lastname@example.org.
*Deciphex provide GLP qualified software. Any customer wishing to use the software for GLP applications will be required to perform the necessary validation as dictated by their regulatory authority for the intended use case