In the pharmaceutical industry, all companies, regardless of their size or area of focus, aim to optimize returns on approved therapies, streamline development processes and minimize trial failures. With the industry poised for further growth and an influx of innovative therapeutics and cell and gene therapies, selecting the most suitable Contract Research Organization (CRO) to form a partnership becomes mission critical.
Outsourcing research projects to CROs is a well-established practice and market reports project a substantial growth rate of nearly 8% in R&D outsourcing until 2030(1). As pharmaceutical companies concentrate on their core competencies by leveraging outsourcing, CROs find themselves presented with a remarkable opportunity. To thrive, they must prioritize strong collaborations, customer service, efficiency, and scalability throughout their operations. While this is applicable across all stages of drug development, it is most paramount in the opening stages.
Toxicopathology services provided by CROs have revolutionized the field, as results from toxicology studies are crucial in evaluating drug-related toxicity and ensuring safety in clinical trials. A recent study highlighted that a standard investigational new drug (IND)-enabling rodent study can yield anywhere from approximately 4800 – 6000 tissue samples(2). For both CROs and their sponsors, the physical volume of slides and data is incredibly high – and so is the risk. They must be right.
In this context, digital pathology is emerging as a transformative solution that is redefining outsourced R&D. Forward-thinking CROs are at the forefront of incorporating this revolutionary approach, recognizing its potential to streamline operations and mitigate risks associated with traditional pathology methods. In a recent survey of life sciences executives, nearly three-fourths of organizations in the life sciences sector have invested in digital pathology to advance their R&D(3). By harnessing the power of digital imaging, collaboration, and artificial intelligence (AI), CROs are helping sponsors drive scientific advancements, optimize efficiency, and contribute to the revolution of personalized medicine.
For CROs that have yet to implement digital pathology, incorporating this technology into their operations offers remarkable advantages for strategic partnerships. What are some of these advantages?
An Operation without Barriers
Digital pathology enhances CRO operations by promoting speed, scalability, and effective collaboration while eliminating potential barriers. This enables the analysis of tissue samples to be unburdened from human error and time constraints. By replacing time consuming, physical slide review with digital imaging, valuable time is saved, and the efficiency of analyzing and interpreting pathology data is improved. The fusion of human expertise and AI capabilities allows CROs to provide sponsors with accurate and nuanced insights, fostering stronger relationships and instilling trust.
Compliance with Regulatory Guidelines
Ensuring compliance with regulatory frameworks, protocols, and quality standards is a crucial and ongoing challenge for CROs. To address this challenge, some digital pathology platforms like Proscia’s own Concentriq® for Research are designed to meet Good Laboratory Practice (GLP) and ISO 27001 guidelines, providing built-in features that facilitate compliance, streamline auditing processes, protect information, and generate comprehensive documentation. This ability allows CROs to maintain a robust and transparent infrastructure, fostering trust and satisfaction among sponsors and regulatory bodies alike.
The Partner a Sponsor Trusts
By leveraging an enterprise digital pathology platform like Concentriq, CROs elevate themselves to trusted partners. Geographical barriers are eliminated, and breakthroughs are accelerated as the CRO becomes an extension of the sponsor’s research team. CRO leaders can have confidence in their teams, knowing they share knowledge and capitalize on synergies. Streamlined processes yield more accurate results, benefiting clients and enabling informed decisions about the safety and efficacy of their INDs or chemicals before human use. This not only reduces costs but also increases efficiency.
A Real Return on Investment
Two key factors influencing return on investment (ROI) are reduced expenditures from slide-based pathology and the creation of new service opportunities for sponsors. Implementing an enterprise digital pathology platform can offer long-term cost savings by replacing traditional glass slide pathology. This is particularly beneficial for scientists located in remote areas, as digitizing slides reduces expenses related to storage, retrieval, and maintenance while eliminating logistic management risks such as lost shipments, slide damage, or loss.
Moreover, certain CROs are strategically leveraging their digital pathology capabilities to offer customized services, including comprehensive reporting and secure storage of sponsors’ images and data. This trend should only grow as the potential impact of AI becomes increasingly evident during the clinical development pipeline. In fact, in 2022, there was a record-high of 11 trial starts for pipeline products utilizing AI/ML in research and discovery(4). This development holds great promise for faster, lower-risk trial results by optimizing drug characteristics and improving trial execution.
Digital pathology represents a paradigm shift in outsourced R&D for CROs. By leveraging its advantages, CROs can excel in providing the best possible services for their clients. The ability to streamline processes, enhance collaboration, and deliver accurate results has the potential to revolutionize the field and propel drug development to new heights. For CRO leaders, adopting digital pathology is not merely an option, it is the key to staying at the forefront of innovation and leading the way towards a brighter future in outsourced R&D.
- Market Research: Grandview Research: Healthcare Contract Research Organization Market Size, Share & Trends Analysis Report By Type (Drug Discovery, Pre-clinical, Clinical), By Services (Clinical Monitoring, Data Management), By Region, And Segment Forecasts, 2023 – 2030
- Mehrvar, S., et al. Deep Learning Approaches and Applications in Toxicologic Histopathology: Current Status and Future Perspectives, Journal of Pathology Informatics, Volume 12, Issue 1, 2021, 42
- 70% Of Major Pharmaceutical Companies And CROs Surveyed Have Adopted Digital Pathology. BioSpace
- White Paper: IQVIA, Global Trends in R&D 2023