Looking ahead to 2026, the clinical research landscape is entering a pivotal phase. As trial design innovations, hybrid studies, and more efficient methodologies gain ground, the role of technology is changing. Tools like IRT/RTSM are no longer just an enabler; they’re becoming the backbone of trial design and execution.
Perceptive eClinical has spent decades developing IRT solutions that meet the industry’s most pressing challenges. We caught up with the company’s CEO and COO to discuss predictions for 2026 regarding trial design, decentralisation, AI, and more.
AI possibilities are growing, but adoption will remain measured
AI was a major talking point in 2025 and use cases will continue to strengthen in 2026. Adaptive trial designs are a key opportunity, with AI potentially helping sponsors respond to emerging data faster. Predictive models for handling complex logistical tasks such as inventory forecasting, expiry management, and shipment optimisation will also become a reality as IRT vendors embed AI into their software within validated, transparent frameworks, offering potential to reduce waste, improve compliance, and flag potential risks early.
But despite the buzz, adoption will remain measured in 2026. “Most organisations are aware of the need to be cautious when implementing AI in our regulated environment, and rightly so, participant safety and data integrity are non-negotiable. AI use is powerful but it needs to be validated and applied with proper oversight,” says Mario Papillon, CEO, Perceptive eClinical.
Concerns persist because AI utilisation is frequently mistaken with full autonomy. In reality, human oversight will remain critical. In 2026, AI uptake will grow where sponsors see regulatory confidence alongside a clear return on investment.
Decentralised and hybrid trials
In 2026, the conversation around the use of decentralised trial elements will shift from “should we decentralise?” to “how do we design trials that truly serve participants?” Trials should be designed for the people they aim to support, meaning there is no one-size-fits-all approach. Nevertheless, hybrid designs are likely to dominate in 2026, offering the best balance of participant convenience and operational control.
“Hybrid designs add another layer of complexity with decentralised elements and dynamic visit schedules,” notes Shaun Hopgood, COO, Perceptive eClinical. “Each approach comes with unique clinical, site, patient and logistical requirements, but technology needs to make these transitions frictionless. Our focus at Perceptive is on building flexibility into our systems so that sponsors can adapt without compromising timelines or data integrity.”
Personalised and precision medicine
The continued rise of oncology and rare disease research will define trial growth in 2026. While oncology will account for most new trials, we’ll also see CNS disorders and cardiovascular disease represent a growing proportion of trial activity, reflecting both unmet needs and a wave of innovation.
In all three of these therapy areas, precision and personalised medicines are accelerating and coming to the fore, bringing enormous promise but also complexity and cost. These therapies are highly targeted, often designed for small participant populations and unique genetic profiles.
“Managing these trials requires precision,” states Hopgood. “Smaller participant populations and high-cost therapies leave no room for error, especially in oncology, CNS, and cardiovascular programs where dosing can be adaptive, titrated, or biomarker‑driven. These investigational products often have short shelf lives and strict handling requirements, creating a zero‑margin‑for‑error environment where every dose counts.”
In addition to narrower participant populations and highly specific dosing regimens, personalised medicines are often extremely expensive and cannot be repurposed across cohorts. Traditional trial designs were simply not built for these challenges.
“It’s creating a new level of complexity in trial design and execution,” says Papillon. “Sponsors need flexibility to respond to emerging data without compromising integrity or timelines. That’s where IRT systems become indispensable. They act as the orchestration layer, managing complex cohorts, enabling mid-study changes, and ensuring compliance across geographies.”
APAC to lead growth
North America is projected to lead in overall clinical trial activity, driven mainly by single-country trials. Asia-Pacific will follow as the second-most active region, indicating substantial growth and ongoing investment in clinical research. Europe will also contribute significantly, with a relatively balanced mixture of single country and multinational trials.
“APAC will remain a growth engine, powered by evolving regulatory frameworks, expanding local manufacturing, and sustained R&D investment,” says Papillon. “Sponsors will need platforms that scale globally while adapting to regional compliance and site level realities. At Perceptive, we see this as an opportunity to lead with innovation, making IRT the backbone for trials that are more complex, more global, and more participant centric than ever before.”
The eClinical ecosystem is evolving
Significant evolutions are expected to take place in the eClinical ecosystem as key players make decisive moves towards interoperability and ecosystem thinking. Sponsors and CROs are tired of siloed systems that create inefficiencies and data blind spots. At the same time, integrations are starting to become a compliance requirement as regulatory bodies emphasise the need for data transparency and auditability.
“The next 12 months will be about making interoperability practical,” says Hopgood. “That means APIs that work, standardised data models, and integration that doesn’t require months of custom development. IRT will no longer be a standalone tool, it will become the workflow orchestration hub that connects EDC, CTMS, analytics, and participant engagement platforms.”
Another technology trend that will gather pace in 2026 is the shift toward modular, cloud-native architectures, driven by sponsors’ need to scale up or down without costly infrastructure changes. Sponsors also need systems that can adapt quickly to protocol amendments, which are increasingly common in adaptive and personalised medicine trials.
“Vendors who can deliver speed of integration, robust security, and intuitive user experiences will lead the market,” notes Papillon.
Key takeaways
2026 will be a year of acceleration, where adaptive designs, decentralised elements, and AI-driven insights become standard practice. The ability to pivot quickly and manage complexity without manual intervention will be a competitive advantage for sponsors and CROs. Trial design will be all about agility and precision, and technology will be the enabler of this.
In 2026, Perceptive eClinical is focused on leveraging automation and interoperability to deliver smarter, faster and more sustainable trials. A new drug forecasting solution will bring game-changing predictive analytics into supply chain management, helping sponsors anticipate supply demands, minimise waste, and avoid delays.
Perceptive is also excited to announce the launch of eCOA into its product suite; available from Q2 2026, a natural extension of its commitment to participant centricity, which will enable richer, real-time data capture directly from participants. Beyond these developments, Perceptive’s mission is clear: to make IRT the intelligent orchestration layer for modern clinical trials.
