This blog is part of a series highlighting how Concentriq for Research drives the phases of the drug development process. Read more about how Concentriq for Research drives translational medicine and the services we offer for Good Laboratory Practice (GLP) peer review.
Preclinical research involving extensive evaluation of the safety and efficacy of the drug or treatment being evaluated is a critical component of the drug development process. During this stage of the development process, biopharma and CRO’s are under pressure to evaluate whether the treatment or drug meets the safety standard to advance to clinical trials. Oftentimes, preclinical research involves collaboration between multiple stakeholders including veterinary pathologists (DVMs) and pathologists who value the quality of the whole slide images generated and the speed of which they can be analyzed.
Prior to the adoption of digital pathology, organizations conducting preclinical research struggled from a number of challenges including data loss or displacement and ineffective ways to collaborate with stakeholders. Oftentimes, these challenges cripple their workflows and even lead to severe disruption of their timelines.
The value of digital pathology in accelerating preclinical research
Digital pathology can help address many of the challenges encountered by CROs and pharma organizations during the preclinical research. For instance, preclinical research often generates high volumes of slide data along with their metadata and any analysis or notes recorded. A robust platform allows your research team to not only effectively organize the digital slide libraries and the associated metadata but also enables your team to easily access research conducted by previous teams. Due to the nature of preclinical research where the data is being reviewed by multiple DVMs, a secure and intuitive collaborative platform allows real-time engagement and asynchronous sharing for colleagues with both internal and external partners. Such features are able to eliminate delays associated with shipment of slides.
Furthermore, oftentimes organizations face the challenge of standardization for grading slides in quality assurance and proficiency testing with reviewers spread out geographically. This can be overcome by implementing a digital pathology platform that allows all researchers to view the same slide and score their results. Differences can then be discussed through a digital slide conference. This ensures that the preclinical study is getting fair treatment, regardless of which pathologist or pathology location conducts the study. Furthermore, digital pathology addresses the challenges associated with data management and accessibility within QA programs, allowing for digital slides to be stored securely and remain accessible to all researchers whenever necessary.
Digital pathology also can help toxicopathologists to focus on the slides that require further analysis. For example, advanced digital pathology technologies in the market are able to offer a solution that helps manage the high slide volume generated when conducting toxicology studies and can thus eliminate the need to look at slides without disease. This allows toxicologic pathologists to put more focus on the slides with lesions so that they can better understand methods of toxicity, providing ways to work most efficiently. They are able to gather, organize, and share data in ways that are not possible with a microscope.
Proscia’s solution to accelerating preclinical research
Concentriq for Research is a configurable and open digital pathology platform that drives workflow efficiency designed to help biopharma organizations overcome the challenges routinely faced by organizations from accelerating preclinical research. We highlighted a few of these key challenges and how Proscia’s solution help address them
- Maximize efficiency of your preclinical studies with a configurabile platform: Configurability is often a challenge for organizations looking to build custom workflows based on their needs. Our platform helps organizations to run studies efficiently through three key areas.
- Configurable project templates: The ability to standardize and consolidate data across the organization encourages the collection of consistent data across studies and facilitates global search. Concentriq for Research allows admin users to create and manage a library of metadata fields for the organization, specifying what the metadata field applies to (such as folder, slide, or annotation) and in what form the data is captured (such as dropdown, checkbox, date, number, and text). Our platform also enables users to create metadata templates, which can be applied to studies of similar types repeatedly.
- Enhanced user management options: Limit access to your system with advanced capabilities to configure granular roles and permissions to control what data is accessed and how much is accessed for research
- Deployment flexibility: Concentriq for Research supports multiple deployment models – on-premise, cloud or a hybrid backend, providing organizations with maximum flexibility to adopt a solution that best fits their needs.
- Maintaining a secure database: Data security is a vital component of preclinical research operations, particularly when that data is being shared with collaborators from other organizations. Concentriq’s security standards offer end-to-end data encryption, and can scale to support the most highly-networked, high-volume digital pathology operations. Proscia’s software embraces a “private-by-default” data management design. Administrators of Proscia software have the ability to configure user roles and access permissions and grant them on an individual basis, restricting access to data to only those users who require it. Administrators also have access to audit logs that provide visibility around integrity of sensitive data.
- Track user initiated changes to your projects via repository audit logs: Tracking user initiated changes are critical to prepare for any potential auditing by regulatory authorities. Concentriq for Research allows teams to download project audit logs containing:
- A timestamp of user-initiated changes made to editable fields
- The user that made the change and
- The action (create/delete/update associated data)
- Facilitating remote review and reducing turnaround time: Scheduling a toxicologic pathologist can be difficult, and they are often pulled into analysis of slides that present complex or unusual lesions. This results in slides being shipped out to another pathologist, a time-consuming process that can potentially extend research timelines. Our digital pathology platform with its powerful collaborative features allows researchers to eliminate interobserver variation and ensure integrity of pathological interpretation via remote slide review. Furthermore, the collaborative mode on Concentriq for Research allows an unlimited number of users to collaborate on whole slide images (WSI) simultaneously. During a live collaboration session, users are able to leave comments using a chat bar which is visible to all users in the session. The system also keeps a history of the comments in collaboration mode for future reference.
- Maintenance and sustainability of data storage: The core of our digital pathology solution is built with powerful image management capabilities. The data gathered in preclinical research can be organized within digital image libraries, making it available and easily accessible for future research efforts – and able to be easily leveraged as new innovations become available. The large amount of slides generated during preclinical research can be associated with the appropriate metadata with our IMS solution that integrates digital slide images with the correct metadata and connects it to the wider laboratory ecosystem through integration with a lab information system (LIS).
- Gather insights via integrated image analysis: Concentriq for Research provides out of the box bi-directional integration with major third party image analysis software. Furthermore, researchers can harness real world evidence and predictive insights with our open and natively computational platform.
- Interoperability with your existing digital ecosystem: Interoperability of an image management system with the existing digital technology ecosystems is critical to ensure smooth operation of a preclinical workflow. Concentriq for Research supports images from all leading scanners. Furthermore, our mature and field-tested open API provides the ability to connect third party software like lab information management system (LIMS), image analysis (IA), electronic lab notebook, and any homegrown AI applications. This enables automation of manual steps and ultimately enhances workflow efficiency helping organizations to reach their full potential. Additionally, our leading interoperability between various systems provides access to the features provided by and data stored within these systems through a single application.
Validating your digital pathology solution for GLP peer review
Many large biopharma companies choose to outsource regulated preclinical studies due to the costly and cumbersome process of maintaining GLP compliance required for toxicologic pathology studies. Concentriq for Research is designed to provide support for GLP peer review of non-clinical (drug safety) studies. Proscia’s operations are guided by an internal quality management system (QMS) to ensure our Concentriq for Research platform is GLP-ready for customers to validate their workflows, a requirement for a GLP-ready solution. Furthermore, Concentriq for Research allows users the autonomy to download project audit logs to support regulatory audits. Concentriq for Research is used by leading pharma and CROs that are intricately involved in evaluating drug candidates for safety and efficacy through their preclinical laboratory studies. Read our blog post “Validating Your Digital Pathology Solution for GLP Peer Review” to learn more!
Accelerate Your Preclinical Research With Concentriq for Research
An open and configurable digital pathology solution with powerful collaborative features can maximize efficiency within your preclinical operations. Proscia’s Concentriq for Research converges digital and computational pathology to harmonize operations across the fragmented and often siloed enterprises. As a partner, we empower your organization to truly leverage the benefits of digital pathology to accelerate preclinical operations and eliminate barriers that slow the progress of advancing your breakthrough research.
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- Potts, Steven J. “Digital Pathology in Drug Discovery and Development: Multisite Integration.” Drug Discovery Today, vol. 14, no. 19-20, Oct. 2009, pp. 935–941, 10.1016/j.drudis.2009.06.013. Accessed 29 Sept. 2019.
- Sewell, Liv. “Digital Pathology in Drug Development: Opportunities and Challenges.” Global Engage, 20 Apr. 2020, www.global-engage.com/lifescience/digital-pathology-in-drug-development-opportunities-andchallenges/. Accessed 4 Oct. 2021.