[Image created via OpenAI image gen]
Amanda Hemmerich
The contrast is stark: the same digital pathology technology routine in hospitals for patient diagnosis can remain elusive in drug development trials. A pathologist with the right setup can digitally diagnose cancer in a clinical setting, but when that same tissue is part of a trial, it often must be shipped as glass slides across continents. The lack of a clear regulatory standard for digital pathology in clinical trials creates a split-screen reality, where diagnostic innovation races ahead while its application in drug development crawls.
Given that large-scale clinical trials rely on a global network of specialists, pathology is an inherently distributed activity, creating significant logistical hurdles for traditional, non-digital workflows. IQVIA employs 30+ pathologists worldwide, with subspecialists spread across time zones. In the past, a hematopathology case requiring a specific expert meant overnight shipping, customs paperwork, and proof that a home office met CLIA certification. “We may need to utilize the people in the United States. This reduces shipping costs and turnaround times,” Hemmerich said. For sponsors, the difference between digital and physical workflows can mean meeting or missing trial milestones.
Building bridges between two worlds
Faced with this divide, companies like IQVIA have become adept at thinking outside of the box. The company has built elaborate infrastructure to satisfy both worlds, delivering digital efficiency where possible while maintaining analog validation for regulators.
The file format challenge exemplifies this bridging effort. While radiology standardized on DICOM decades ago, digital pathology scanners from different vendors produce incompatible proprietary formats. “We had to implement a solution. We found a company that will convert our files that we scan into whatever file format the client would like,” Hemmerich explains. “But this takes time. This is a very manual process.” For a company managing thousands of trial sites globally, each format requires separate validation protocols, specialized training and conversion workflows that can add days to sample review timelines.
Kelli Aufderheide
The workarounds extend beyond pathology slides. Until recently, every trial kit leaving IQVIA’s facilities contained at least one paper requisition form, often multiple pages. Lab manuals ran 100 to 150 pages. Sites managed stacks of collection instructions and shipping documents. “Before that, unless we were using third-party software, every single kit that left our building had a piece of paper in it,” says Kelli Aufderheide, who focuses on decentralized clinical trials at IQVIA. The company launched its Site Lab Navigator with e-requisition capabilities in March 2025, digitizing these workflows even as many sites still prefer paper.
Even AI deployment reflects this dual-track reality. While diagnostic pathology increasingly leverages AI for primary diagnosis support, IQVIA uses it primarily for workflow optimization in trials. Algorithms prioritize urgent cases, highlight areas of concern, and handle tedious tasks like mitotic counts or calculating tumor percentage for genomic testing. “It’s an assistant, not a replacement,” Hemmerich says. “It helps us pick out what’s most important and makes sure we’re on top of it.”
Yet these same algorithms could do much more. Machine learning can quantify features invisible to the human eye: ratios of membranous to cytoplasmic staining that could identify which patients will respond to treatments. “I’m interested in seeing how we can find better cutoff points for patients to really know who’s going to benefit from a treatment and who’s not,” Hemmerich explains. The technology exists; the regulatory framework doesn’t.
Digital infrastructure does enable some immediate wins. IQVIA’s standard protocol requires two independent pathologists to review each case, with a third reviewing if they disagree: “two plus one adjudication.” Previously, this meant shipping slides to multiple locations or gathering specialists around a multi-headed microscope. “It’s much easier to manage all this on the electronic image management system than to get everybody around a multi-headed scope, especially if we’re not all in the same lab,” Hemmerich says.
Sponsor pathologists can now access IQVIA’s systems directly, annotating slides and providing feedback without waiting for shipments. “Did you see this? This is what I’m talking about here. Has this been included in our study?” Hemmerich describes the typical back-and-forth. “We can have that nice collaboration, not just internally but also externally.”
Building a foundation for an uncertain future
Despite regulatory uncertainty, IQVIA is making a calculated bet: building infrastructure for regulations that don’t yet exist. The company validates equipment beyond current College of American Pathologists recommendations, essentially over-engineering for a future that hasn’t been approved.
“Though it’s not necessarily needed right now for exploratory studies to have that level of validation, we’re doing it anyway to prepare for the future,” Hemmerich says. It’s an expensive bet: maintaining dual systems, training pathologists on digital workflows they can’t fully use and investing in conversion technologies that shouldn’t be necessary. But it supports scale.
Sidebar: Digital pathology by the numbers at IQVIA
- 30+: Pathologists at IQVIA globally
- Multiple: Proprietary scanner formats requiring conversion (industry has 10+ major vendors per research)
100–150: Pages in a typical printed lab manual, now digitized (ballpark figure, per Aufderheide)
March 2025: Launch of IQVIA’s Site Lab Navigator with e-requisition- “Thousands”: Trial sites in IQVIA’s global network
24–48 hours: Typical data entry delay eliminated by digital requisitions (per interview)
The strategic thinking extends beyond pathology. The industry’s approach to decentralization has matured since the pandemic-driven surge of 2020 to 2022. Rather than pursuing universal remote collection, companies now target specific scenarios. “It’s becoming more targeted to certain patient populations that would greatly benefit from that type of collection, but also targeting therapeutic areas,” Aufderheide explains. A cancer patient receiving weekly infusions might still visit a site, while a rare disease patient hundreds of miles from the nearest center could benefit from home collection.
This selective approach reflects hard-won lessons about digital transformation. As Aufderheide observes: “We see that across any of the applications we’re trying to implement… resistance at first, then acceptance, then adoption.” The company has already digitized lab manuals, reports and queries through electronic portals. But with thousands of trial sites globally, adoption remains uneven.
The bet is that when regulations do shift, sponsors will want partners who’ve already worked through the technical and operational challenges. Those still shipping glass slides and managing paper requisitions will face a steep learning curve. Companies that have been validating equipment, training staff, and refining digital workflows will be ready to move immediately.
For sponsors evaluating their pathology strategies today, the choice is whether to wait for regulatory clarity or invest alongside companies like IQVIA in building tomorrow’s infrastructure. Even without full regulatory approval, digital systems deliver immediate benefits. “We’re leveraging it for sample management, tracking, making sure all the protocols are in place, making sure everybody can see it in one unified system,” Hemmerich notes.
Filed Under: machine learning and AI
