Clinical trials at the core: Decentralised, AI targeted, ESG mindful

The clinical trial landscape in 2025 was characterised by technological advancements, regulatory innovations, and a focus on diversity and patient engagement, alongside challenges such as declining trial initiations and logistical complexities.

For Steve Sanghera, co-founder and CEO of Inventus, and Jim Michel, co-founder and Chairman, 2025 was the year clinical trial enablement really started to move from experiments in decentralisation to a more pragmatic, platform-driven model. Implementation – at scale – is not far off.

Industrialisation of the digital toolkit

“If the last few years were about experimentation, 2025 was about industrialising the digital toolkit when it comes to technology and innovation,” commented Sanghera. “For Inventus, the focus was not just on new features, but on the join-up: fewer logins for sites, smoother set-up for sponsors, and a consistent patient experience.”

Indeed, Inventus provides bespoke technology and end-to-end solutions to enable and support successful clinical trials. Their work helps to make sure researchers can efficiently gather reliable data, protect patient privacy, and reduce the cost and complexity of trials.

So, what will 2026 hold? According to Michel, for Inventus, 2026 will be the year “where there will be more of a deepening and normalisation of trends that have been building over the last three to five years.”

“2026 will be the year where pragmatism and integration join forces to ensure fewer silos and more connected ecosystems,” predicted Michel. “There will also be more pressure to prove that technology in clinical trials is delivering real value to patients, sites, and sponsors.”

The changes and trends seen in the clinical trials sector in 2025

This year, sponsors and CROs shifted away from stitching together multiple point solutions and instead looked for integrated partners who could combine devices, telehealth, logistics, data, and support into a single, coherent stack.

“That played directly to our sweet spot at Inventus,” noted Sanghera, “being able to talk about devices, connectivity, fleet management, and data as one continuum, rather than four separate workstreams. At the same time, decentralised and hybrid trials have continued to scale, but with a more realistic lens: what can go remote, what must stay on-site, and how we can reduce burden on sites and patients, rather than simply “digitising” everything”

Market forecasts now show decentralised trials growing at double-digit rates over the rest of the decade, underlining that this is no longer a niche, but a structural shift in how trials are designed and executed.

Three areas stood out for Inventus in 2025:

• Digital biomarkers and continuous monitoring: There was a clear acceleration in the use of wearables and connected devices to move beyond simple activity tracking into richer, protocol-relevant endpoints – for example, gait, tremor, sleep architecture, or cardiometabolic risk markers. “Studies show that targeted use of wearables can improve compliance and outcomes in decentralised and hybrid trials,” said Michel, “which aligns with the direction of our own telehealth and device portfolio.”
• AI in recruitment, risk prediction, and operations: AI moved out of the hype phase and into more targeted, high-value use cases, such as identifying eligible patients from real-world data, predicting site performance, or detecting safety signals earlier.
• Sustainability and circularity in clinical tech: There was also a noticeable uptick in research and piloting around circular device models – how to recover, refurbish, and repurpose clinical hardware safely, securely, and at scale. “That has been core to the Inventus model from the outset,” explained Michel, “so, it has been encouraging to see ESG move from “nice to have” to a board-level requirement in RFPs.”

The effects of external political, economic, and social forces in 2025

“All three elements combined to make 2025 a challenging environment for clinical trials, but at the same time allowed for clarity,” noted Sanghera.

This can be broken down into:

• Cost pressure and medical inflation: These kept the focus firmly on value. Sponsors expected clear evidence that technology reduces cycle time, site burden, and rework, not just adding another budget line. Global medical cost trends remained high, keeping procurement highly disciplined and pushing vendors to demonstrate ROI.
• Component and supply chain volatility: This continued, especially in electronics and connectivity, which impacted timelines and pricing across the sector. “For a device-led business like ours, that forced even more creativity around fleet reuse, refurbishment, and secondary rental models,” explained Sanghera, “areas where our circular economy approach has been a real differentiator.”
• Regulation around AI and software as a medical device tightened: This was particularly so in Europe. The EU AI Act and parallel reforms in medical device regulation began to crystallise what “high-risk” AI looks like and what evidence and governance frameworks are required in healthcare and life sciences.
• Tariff wars: Unprecedented volatility within global tariffs caused uncertainty within procurement strategies.

Nonetheless, 2025 was an exciting time for innovation and technology in the clinical trials space:

• Telehealth platforms became more clinical-grade, with better audio-visual quality, integrated workflows, and the ability to support more complex assessments remotely.
• Device management matured. “Instead of generic MDM tools, we have found sponsors increasingly seek trial-specific fleet management, FOTA control, and support tooling – exactly the space where our Inventus IDM and e-sim connectivity capabilities sit,” Michel said.
• Data platforms began to bring together EDC, eCOA, device feeds, and real-world data into unified views to support “risk-based everything” – monitoring, quality, and decision-making.

Predictions for 2026

Inventus expects several 2025 trends to intensify in 2026:

• Decentralised and hybrid trials: These will become the default design choice in many indications, particularly where remote monitoring, telehealth, and wearables can clearly reduce burden without compromising data quality. “The underlying market for decentralised trials is projected to continue strong double-digit growth into the 2030s, so 2026 will be another step along that curve,” noted Sanghera.
• Targeted use of AI: This will continue to grow – especially in feasibility, site selection, recruitment, and operational risk prediction – but under much stricter governance as regulators and legal frameworks bite.
• ESG expectations: Focused around device recovery, e-waste, and carbon impact, these will move from “nice messaging” to formal RFP requirements, which suits Inventus’ circular economy model.

As for the effects  of external political, economic, and social forces in 2026, for Michel economically, they “don’t expect cost pressure to ease.”

“Medical and pharmaceutical cost trends are forecast to remain elevated into 2026, which will keep procurement sharp and shift more focus to technologies that clearly shorten timelines or prevent costly protocol deviations and dropouts,” Michel explained.
Politically and legally, 2026 will be a regulation-heavy year for anyone using AI, software, and connected devices in trials, especially in Europe:

“Implementation milestones under the EU AI Act and related liability reforms (such as the updated Product Liability Directive due by December 2026) will push sponsors and vendors to formalise risk management, documentation, and transparency for “high-risk” systems used in healthcare and life sciences,” he continued. Adding: “Ongoing debates around drug pricing, market access, and healthcare cost containment will reinforce the need to run trials more efficiently and more globally, and to capture high-quality evidence that supports value-based arguments early.”

Furthermore, socially, expectations around equity, access, and patient experience will continue to rise.

“Communities that have traditionally been under-represented in clinical research will expect genuine progress, not just rhetoric, which will amplify the demand for telehealth, home-based visits, and more inclusive recruitment strategies,” commented Michel.
Revealing several predictions using the ‘Inventus lens’, for Sanghera, 2026 will bring:

1. Vendor consolidation:
“We expect at least one or two significant acquisitions or mergers between major eClinical / DCT / logistics players as sponsors push for integrated stacks and fewer contracts to manage.”

2. ESG moving into contracts:
“By the end of 2026, we predict that the majority of large pharma RFPs in our space will include explicit requirements around device recovery, recycling, and carbon reporting. We expect vendors who already have mature circular models to be rewarded.”

3. Telehealth as a standard, not an exception:
“Telehealth will be written into protocols as a standard visit option across multiple therapy areas, not just as contingency or for rare disease or COVID-era designs.”

4. First “test cases” under new AI frameworks:
“We also anticipate at least one high-profile regulatory or legal case relating to AI used in healthcare or clinical research in Europe, which will set important precedents for the entire sector.”

About the authors

Steve Sanghera is CEO and Co-Founder of Inventus. His extensive career spans over 20 years in mobile technology and financial solutions, including several senior roles with companies including Caudwell Group and Ikon Office Solutions. Sanghera also spent two years in an advisory role for the New York Stock Exchange focusing on the global mobile telecommunications industry. Over the last ten years, he has taken his previous learnings and channelled them into entrepreneurial activities, striving for a positive impact and creating change for the better.

Jim Michel is Chairman and Co-Founder of Inventus. A former MD of Brightstar, Michel is a respected name in the world of mobile technology. He co-founded Inventus with a clear vision in mind: technology should serve to create meaningful impact and change. It is a goal he is proud Inventus has achieved as the only company in the world to create tailored tech devices for use in the clinical trials space.

About Inventus

Inventus is the world’s only company dedicated to creating bespoke technology solutions designed exclusively for clinical trials. As a global technology solutions leader, Inventus is pioneering the delivery of smarter, more efficient trials while always thinking about the patient and site experience. Working in partnership with the largest pharmaceutical companies in the world, Inventus’ technology solutions provide participants with confidence that their data is secure and that their experience from start to finish will be seamless and efficient. Over the last five years, Inventus has deployed more than 600,000 devices across a multitude of therapeutic areas and countries, with support for 586 languages anyone, anywhere in the world, can use its solutions with ease. Inventus is at the forefront in delivering preventative health technology solutions while driving clinical trials through connected technologies and fully sustainable device programmes that ensure zero waste.