Clinical trial sponsors are navigating a landscape of increasing complexity. A team of researchers recently set out to explore this phenomenon through a machine learning analysis of data from over 16,000 trials across the previous decade. Assessing key features such as the number of endpoints and inclusion-exclusion criteria, Markey et al established a new metric that they called the Trial Complexity Score, ranging from 0 to 100%, with lower scores correlating to less complexity as well as lower trial durations. From 2011 to 2022, the researchers found complexity scores had increased by more than ten percentage points across all three trial phases studied. Phase I trials increased from the low-20s to the mid-30s, while Phase II and III increased from the mid-40s to the low-to-mid 50s.[i]
Not only are protocols more intricate, but operational hurdles continue to cause challenges in their implementation. Global site coordination remains a logistical challenge, while patient recruitment also continues to be a bottleneck. Meanwhile, there is a consensus that the industry needs to move toward decentralised and hybrid trials, adding another layer of operational demand as trial models evolve.
Other challenges stem from drug modality trends, particularly as personalised medicine gains traction. With trials often involving high-value biologics or cell and gene therapies, patient populations become smaller and much more specific. In such trials, investigative medicinal products (IMP) are expensive and limited in supply, putting greater emphasis on accurate drug allocation, real-time inventory visibility, and precise patient randomisation.
Amid all of these challenges, technology demands increase. The growth of DCTs, for example, requires technology that can adapt quickly and support seamless execution across diverse geographies and trial models, while the rise of personalised medicine requires highly reliable and responsive Interactive Response Technology (IRT) systems that minimise drug waste.
Technology partners must step up
The tech ecosystem itself is becoming increasingly complex in today’s digital world, and this in turn is creating growing need for eClinical systems capable of not only adapting to complex study requirements but also working in harmony with the various tools and platforms that each stakeholder relies on, including EDC, CTMS, eConsent, and site-facing portals.
“The ability to connect seamlessly is now a baseline expectation,” says Shaun Hopgood, chief operating officer at Perceptive eClinical. “Sites in particular are often burdened with multiple systems across different sponsors and trials. Configurable platforms that can adapt to workflows and reduce friction are essential for improving engagement and data quality. When systems are designed to flex around site workflows, rather than forcing sites to adapt to rigid technology, it reduces friction, training time, and the risk of errors. This leads to cleaner data, faster execution, and better collaboration between sponsors and sites.”
More importantly, he adds, this also gives site staff their time back by streamlining administrative tasks and reducing the burden of navigating multiple platforms, allowing more time to focus on patient engagement, protocol adherence, and high-quality care.
Configurability is becoming essential
Another requirement is the growing demand for self-service. “Sponsors and CROs increasingly want autonomy over aspects of study setup and management, whether it’s adjusting visit schedules, managing inventory thresholds, or updating site parameters,” says Mario Papillion, Perceptive eClinical CEO.
This is another area where configurable platforms come in, empowering teams to take control of their studies while staying within validated frameworks.
Configurability is not to be confused with customisability, however. Customisable platforms typically rely on bespoke development, and this can be slow, costly, and difficult to scale. Configurable platforms are quite the opposite.
“Configurable platforms offer built-in flexibility through intuitive interface, rule engines, and modular components. They allow study teams to make changes quickly and safely without needing to go back to developers for every adjustment,” explains Hopgood.
“One of the most powerful aspects of configurability is the ability to introduce self-serve elements, but configurability also supports broader interoperability,” he adds. “Different sponsors use different systems, and sites are often juggling multiple platforms across trials. A configurable system that can integrate easily with EDC, CTMS, and site-facing tools ensures smoother collaboration and less friction across the board.”
The next generation of IRT is coming
According to Mario Papillon, Perceptive eClinical is currently undergoing a strategic transformation, the goal being to evolve from a traditional IRT provider into a fully agile eClinical platform.
“Our architecture is being rebuilt around microservices, APIs, and low-code configuration layers,” Papillon explains. “We’re already seeing the benefits in faster deployments and more adaptive study builds. The next phase is deeper integration across the clinical ecosystem, bringing together IRT and other eClinical solutions into a unified, configurable experience.”
While cutting-edge software practices such as low-code frameworks, containerized microservices, and cloud-native infrastructure are powering this evolution, Papillon and Hopgood insist it’s also the people at Perceptive, and their deep experience, which are driving the innovation.
“Perceptive has over 30 years of experience in clinical trial technology – our teams bring an unmatched depth of knowledge in IRT, regulatory compliance, and global study operations,” says Papillon. “We’ve assembled a group of passionate, forward-thinking professionals who understand the nuances of clinical research and are committed to solving real-world problems for sponsors, CROs, and sites.”
This gives Perceptive a unique vantage point. The company is a legacy pioneer in Interactive Response Technology but is moving much like a newer, disruptive player. Perceptive eClinical has supported upwards of 4,700 trials, as well as 500 regulatory approvals. As Papillon says, its team understands the regulatory landscape, the operational realities of global trials, and the critical importance of data integrity and compliance. Now, this legacy forms the foundation for its transformation.
“We’re combining our proven track record with a fresh, agile approach,” agrees Hopgood. “We’re building configurable, interoperable systems that meet the evolving needs of sponsors, CROs, biotechs, and sites. Our solutions are designed to integrate seamlessly with the broader eClinical ecosystem, empowering teams with more autonomy and reducing the burden on sites so they can focus on patient care.”
Overall, the clinical trial landscape is evolving, with intricate protocols, changing trial models, and an often overwhelming technology ecosystem as just some of the increasing challenges that teams face. Sponsors are demanding more flexibility from their technology systems, and this requirement comes from a need for better interoperability just as much as it comes from a study design perspective. In response to these challenges and requirements, the focus for agile technology providers like Perceptive eClinical is on delivering configurable, cloud-native systems that work across diverse environments, enabling sponsors and their partners to move faster, collaborate better, and deliver trials more efficiently.
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[i] https://pmc.ncbi.nlm.nih.gov/articles/PMC10861486/
