Steve Jobs famously said that the most precious resource we have is time. It’s a sentiment that drives people to ponder how much time they have and how they can make the most of it.
But in the pharmaceutical industry, it’s different: time is something we compete against. Pharmaceutical, biopharmaceutical, and contract research organizations (CROs) continuously race to deliver new medications and treatments that will help people survive and thrive.
So, when I talk to industry leaders, it’s no surprise that they are always looking for new ways to accelerate their preclinical discovery and development cycles. The faster their teams can create, validate, and deliver new therapies to market, the more lives can be saved and changed for the better.
What’s the biggest obstacle to achieving this goal? Without a doubt, it’s the manual processes and non-integrated point solutions that make it difficult to validate the intended use and meet the FDA’s good laboratory practices (GLP) requirements.
Elevate GLP Compliance with Modern Pathology Workflows
Regulations such as the Good Laboratory Practice for Nonclinical Laboratory Studies Regulations and 21 Code of Federal Regulations (CFR) Part 58 have been around for more than 40 years. They are designed to eliminate poor research practices and laboratory misconduct, helping ensure the safety of FDA regulated products.
GLP addresses the organizational processes and conditions under which organizations plan, perform, monitor, record, report, and archive their studies. These requirements ensure the quality and integrity of safety test data, the reporting of verifiable conclusions, and data traceability.
For preclinical R&D, a huge proportion of the data assessed and validated for GLP is pathology data. We’ve seen that preclinical R&D processes require more pathological data than perhaps any other phase of drug discovery and development.
That’s why it’s so surprising that many pharmaceutical companies and their CRO partners still process pathology data using analog solutions, manual processes, and point tools. It’s not because these approaches deliver great outcomes. In fact, customers using these legacy approaches say that they struggle to consolidate their preclinical R&D data – for both GLP and non-regulated studies.
What’s more, the pathology workflow experience for users is slow, cumbersome, and inefficient. To enable primary and peer reviews of whole slide images (WSIs), pathologists and administrators often spend hours packaging and shipping slides to colleagues and CROs or traveling to meet with peers.
Choose a Solution that Helps You Collaborate to Innovate
To accelerate preclinical discovery and development and comply with GLP requirements, you need to look for a single unified digital pathology platform. This platform should be able to handle all of your preclinical R&D needs, so you can conduct GLP studies on the same platform as your non-regulated discovery and preclinical research.
And don’t forget the user experience. Seek a platform that delivers terabytes of rich image and study data with a single click. It should also boost workflow efficiency by enabling automated data capture – of images, metadata, and annotations from scanners, spreadsheets, and laboratory information management systems (LIMS).
Your pathology professionals need to collaborate, share knowledge, and uncover new insights. They can only do that if you deploy a fully integrated pathology R&D ecosystem with an open API and easy-to-use tools.
Meet All of Your Pathology Data Needs
The right digital pathology platform can support several critical use cases:
GLP-regulated primary review: To help your pathologists and toxicologists review large volumes of slides, look for robust, intuitive viewing capabilities that can improve the efficiency of preclinical studies. Annotations and metadata tools enable reviewers to add observations and findings. Built-in study controls with roles and permissions, 21 CFR part 11 compliance, audit logs, and validation support help ensure GLP compliance during primary review.
GLP-regulated peer review: Your administrators and users want to support peer review and collaboration – but without shipping WSIs or traveling to meet with other pathology professionals. Choose a digital pathology platform that offers a seamless workflow to execute and manage peer review activities in a GLP-compliant environment. Advanced administrative roles and permissions help users digitally share studies with collaborators and receive data for peer review – all while maintaining data security and access levels. To help administrators maintain study controls, prioritize features such as audit log and reason for change, history, and sign-off (which should be compliant with 21 CFR Part 11).
Automated quality control of WSIs: To improve data integrity and image reliability, look for solutions with an AI-powered, automated quality control (QC) feature that detects common quality issues in hematoxylin and eosin (H&E), immunohistochemical (IHC), and special stained slides. By eliminating the manual QC process for massive volumes of data, this technology can improve workflow efficiency by allowing your administrators and study coordinators to review WSIs and re-stain or re-scan slides as needed before primary review. It also should be able to carry over regions of interest to image analysis applications, further improving the quality of data.
Get Everything You Need in One Digital Pathology Platform
Concentriq for Research by Prosica offers everything you need to accelerate your preclinical discovery and development cycles. In addition to all of the features mentioned above, this advanced digital pathology platform offers:
- GLP compliance features such as audit logs, enterprise administration, and archive workflows
- An AI-powered automated quality control module that helps scientists detect common quality issues in slide images
And that’s just the beginning. In the coming months, we plan to add the following enhancements:
- Next-generation audit log that captures all user actions and produces a filterable, easy-to-read audit log that is secure and time-stamped
- Access to archived projects, enabling data mining with view and search access to study data, helping you take full advantage of your digital R&D assets
- Repository controls, allowing users to enter a reason for change for any modifications to your preclinical study data and helping you comply with GLP regulations
- A studies module that enables WSI scoring and peer review, streamlining toxicopathology workflows
Validate with Proscia Services
We know that validating a platform for GLP applications is resource-intensive and time-consuming – and it requires an understanding of your organization’s current and future R&D needs.
That’s why we created a service offering to help you with the validation process. Our guided professional services team works closely with you to validate our platform for your GLP applications.
Proscia’s operations are guided by our internal quality management system, which ensures that Concentriq for Research is GLP-ready to validate your workflows and that it meets industry compliance guidelines.
In addition, we take time to understand your workflows and specific use cases. We offer suggestions on user acceptance testing scripts for predefined Concentriq-related workflow elements. We also can assign a project manager to help you create a plan to validate your Concentriq for Research platform.
Discover the Value of Concentriq for Research
Time is short and you need to make the most of every moment to succeed in the pharmaceutical industry. Our digital pathology platform helps you drive efficiency and quality gains in your preclinical studies while capitalizing on the promise of your data. To learn more about how Concentriq for Research streamlines preclinical R&D while enhancing efficiency and quality, read this interview. Or watch this webinar to learn how digital pathology can improve preclinical R&D by streamlining routine operations, improving the reproducibility of results, and making better use of pathology data.