In vitro diagnostics (IVDs) inform nearly two-thirds of clinical decision-making, yet account for only about 2% of U.S. healthcare spending. From early detection to treatment monitoring, IVD manufacturers are continuously looking for ways to deliver patient outcomes faster and more efficiently.
In a recent panel discussion, clinical thought leaders shared how their organizations are adapting their operations and technology to keep pace with rapid change in the IVD space.
The Current IVD Landscape
In contrast to traditional pharmaceutical or medical device trials, IVD “patients” are often a tissue or blood sample, rather than a person. This impacts regulatory requirements, study design, and even how success is measured. IVD’s sometimes understated role in clinical trials in conjunction with its unique testing can lead to bottlenecks and inefficiencies.
A director of data management at a leading global medtech, explained how his organization focuses on lateral flow assays, recently expanding from bench work into full clinical trial support. Their lean team of data managers, statisticians, and CRAs works on short, intense studies that can see 500+ participants recruited in just four months. To manage this large volume, his organization leverages pre-built form libraries in Veeva EDC to spin up studies quickly, a necessity during the respiratory disease rush season each fall and winter. “With form standardization, we don’t need to reinvent the wheel each time. This makes everyone’s life easier and allows our clients to submit on time.”
For a leading device manufacturer in the immunohistochemistry (IHC) space, teams conduct external validation studies that rely heavily on case reports and pathology forms. A senior clinical development scientist for their global clinical affairs team explained how they’ve aligned standardized templates with the bespoke needs of pathology-driven studies in Veeva EDC, a balancing act between consistency and customization.
These are challenges that a senior director of clinical operations at companies including Roche, Illumina, and GRAIL, knows all too well. He’s led large-scale validation and reproducibility studies for pharma clients, dealing with massive datasets from next-generation sequencing (NGS) across various organizations. Now, he’s focused on leveraging automation to handle massive data volumes, hoping to eliminate costly manual checks.
Collaboration and Companion Diagnostics
The panelists also explored the future of companion diagnostics (CDx), which match patients to targeted therapies based on their genetic or molecular profiles. Growth in precision medicine is creating both opportunities and bottlenecks.
One innovative leading medtech sees a rising role for patient-reported outcomes (ePRO) to measure not just clinical accuracy, but also ease of use and quality-of-life improvements.
A leading device manufacturer in the IHC space echoed the need for scalable systems that can handle the growing volume and complexity of CDx studies, especially as bridging studies and interlaboratory reproducibility testing become more common.
For the senior director of clinical operations, he sees how early feasibility and proof-of-concept studies with pharma partners are becoming more important, but data-sharing between pharma and diagnostics remains slow and cumbersome. However, “with a tool like Veeva, teams could shave weeks or months off timelines,” he said.
Lessons Learned
When reflecting on their Veeva EDC implementations, the panelists provided key insights to help others that may be going down a similar path:
What’s next
The discussion concluded with a forward-looking perspective, examining regulatory changes in Europe and the U.S. and the broader implications of geopolitical shifts on global supply chains. The IHC device manufacturer is closely monitoring evolving regulations worldwide and is scaling up its operations to manage larger and more complex studies. Another leading global medtech is adapting to the FDA’s new approach to respiratory diagnostics while also concentrating on integrating ePRO (electronic patient-reported outcomes) into its processes.
Despite different challenges, the panelists agreed on one thing: in IVDs, speed, accuracy, and adaptability aren’t just nice-to-haves — they’re essential for improving patient outcomes in a rapidly changing world. Having a specialized partner like that understands the complex needs of diagnostics is crucial to running an efficient and effective study.
For more details about the significant benefits digitalized systems could bring to IVD studies, read more here.