Latest News: Proscia Receives FDA 510(k) Clearance For Concentriq AP-DxREAD THE PRESS RELEASE

Preclinical R&D: What’s new for GLP and non-regulated studies

By Proscia | March 20, 2023

One of the many reasons why I joined Proscia is our ongoing investment in people, platform, and technology evolution, and especially because of our continued expansion into the preclinical and clinical markets, from where I came. 

I am super excited we are expanding further into preclinical R&D to help drive faster drug safety decisions, help toxicologists, pathologists, and scientists to realize the value of modern digital pathology, and improve throughput and quality for exploratory AND regulated studies.

Preclinical R&D is where the rubber meets the road… and fortunes are won and lost.  

Heading over to preclinical R&D from discovery and research are thousands of lead candidates for further development and exploration. But before these lead candidates can get into a clinical trial, they must be proven to be safe and effective, and safety comes first!

To ensure safety, toxicologists, pathologists, and scientists must evaluate tissue samples of every organ of every animal, including both genders, of multiple dosage levels, and from several studies for each drug candidate that comes into preclinical R&D. Preclinical R&D generates more pathology data than any other stage of drug discovery or development – even more pathology data than research or clinical trials. And due to the high volume, many pharma and biopharma companies outsource a huge percentage, if not all, of their pathology specimens. This is one area where CROs come in to partner with drug development companies, providing focused expertise in toxicology and pathology services to help meet the demand.

Delays in preclinical development can cost as much as $8 million of revenue per day. And, if instead of using digital images, you are shipping around glass slide specimens, from site to site or organization to organization, the days, damage, and delays really add up!  

Being careful with your slides, and not fully utilizing other departments or CRO partners, is not an option.

Then there is the extra burden of ensuring top quality pathological assessments in both non-regulated, exploratory studies and GLP studies. CROs want and need the flexibility of using a digital pathology solution for both non-regulated and GLP studies. Many pharma and biopharma companies would also like and need this flexibility. But until recently, most digital solutions have been optimized for one or the other, are point solutions and not a platform, cannot easily integrate with other technologies, and are not interoperable across multiple scanners and LIMS systems.  

So, flexibility goes out the window, and you get locked into using multiple technologies for different types of studies and tasks.  This does not improve throughput or quality, and certainly does not improve your total cost of ownership over time for digital pathology.

Help is on the way! 

Guess what’s new for GLP and non-regulated studies? A single platform for all preclinical R&D needs. With our continued expansion for preclinical customers, we have extended the robust functionality and compelling user experience of Concentriq for Research to provide a modern, scalable digital pathology platform that includes:

  • A new Studies module that streamlines toxicopathology workflows. Concentriq for Research now enables whole slide image scoring and peer review with a new Studies module. Scientists can manage study frameworks, simultaneously collect pathologists’ assessments, and instantly evaluate results, easily capturing structured data to help improve reproducibility and drive more efficient analysis.
  • New technical controls for Good Laboratory Practice (GLP) compliance. Life sciences organizations can conduct GLP studies in the same platform as their non-regulated discovery and preclinical research. In addition to audit logs, enterprise administration, and archiving workflows on Concentriq for Research, we’ve also made available GLP validation services to help teams realize the benefits of digital pathology sooner.
  • Automated Quality Control for even more pathology data. The platform’s AI-powered Automated QC has been expanded to detect commonly occurring quality issues in every image of H&E, IHC, and special stained slides, eliminating the manual QC process for massive volumes of data. Regions of interest can also be carried over to image analysis applications, further improving the quality of data driving preclinical R&D.  Now you have gained efficiencies by not wasting your time.

This – our further expansion for preclinical R&D, and our continued investment in people, technology, and the comprehensive digital pathology platform we provide – is why I am super excited to have joined Proscia. And this is why 14 of the top 20 pharmaceutical companies use Concentriq for Research.  

We provide a singular platform for the R&D value chain, from drug to market. The Concentriq for Research platform connects multi-site teams with their data, applications, and workflows, enabling life sciences organizations to overcome silos, increasingly tap into pathology data across studies, and accelerate the next wave of innovation. 

Join our upcoming webinar!
New in Concentriq for Research 3.9: Expanded Capabilities for Preclinical R&D
May 3, 2023 @11:00AM ET
Register Here

Our website uses cookies. By using this site, you agree to its use of cookies.