eClinical Solutions Highlights 2025 Shift to Risk-Based Strategies and AI in Clinical Trials
eClinical Solutions LLC, a global leader in digital clinical software and services, has released the findings of its 2025 Industry Outlook, offering critical insights into how clinical data professionals across the biopharmaceutical, biotechnology, and contract research sectors are preparing for the future. Now in its third year, the annual report draws from survey responses of 135 clinical data experts and provides a nuanced view of how organizations are prioritizing advancements in technology, people, and processes—particularly in the context of artificial intelligence (AI) and risk-based strategies.
The 2025 edition of the report paints a more tempered picture of AI enthusiasm compared to previous years. While adoption remains a focus for many, the breakneck pace of exploration and implementation seen in 2024 has slowed. According to the data, 72% of respondents are either integrating or considering integrating AI into multiple facets of their clinical trial operations—a modest increase from the previous year. However, there’s also a notable uptick in the number of organizations expressing no interest in pursuing AI solutions at all.
This shift suggests a growing maturity in how life sciences organizations are evaluating AI technologies. Many early adopters have transitioned from exploration to strategic deployment, while others are taking a more cautious approach, focusing on foundational improvements in their operational frameworks before diving into advanced tools. As a result, risk-based approaches are taking the spotlight. These methods, which involve proactively identifying, assessing, and mitigating risks in trial execution, are increasingly viewed as having the greatest potential to drive improvements in trial quality and operational efficiency over the next 12 months.
Compared to last year’s data, nearly double the number of respondents now believe that risk-based strategies will have the most significant impact on improving trial outcomes and streamlining execution. This shift underscores an industry-wide pivot from technological hype toward practical, outcome-oriented approaches that are rooted in optimizing existing processes and infrastructure.
Balancing Technology with Process and People
The survey also reinforces the industry’s growing recognition that the success of any technological initiative—including AI—relies heavily on robust processes and skilled personnel. One of the most prominent takeaways is the emphasis on real-time data access, with 59% of participants citing it as a high priority. The ability to access and interpret clinical trial data across teams without delay is no longer a luxury—it’s becoming a fundamental requirement for effective decision-making and timely trial management.
Despite the acknowledged importance of real-time data access and risk mitigation, only a third of respondents rated their current technology stack as “very effective” at managing clinical trial risks. This disconnect points to persistent infrastructure gaps and highlights the ongoing challenges organizations face in harmonizing complex datasets across disparate systems.
Interestingly, while nearly two-thirds of those surveyed reported that they are currently using or considering AI applications, 98% of this group acknowledged facing at least one significant challenge. On average, respondents identified 2.5 pain points in their AI journeys, the most common being related not to the technology itself, but to implementation processes. Regulatory compliance, data privacy concerns, and difficulties in quantifying return on investment were among the most frequently cited hurdles.
This feedback suggests that the industry is reaching an inflection point in its adoption of AI—not necessarily stepping away from the technology, but becoming more discerning in how it’s implemented. Rather than chasing every new development, life sciences organizations are now seeking ways to use AI to rethink traditional workflows, enhance data management practices, and improve analytics capabilities across the clinical trial lifecycle.
Leadership Commentary: Building the Foundation for Innovation
Raj Indupuri, CEO and co-founder of eClinical Solutions, emphasized the importance of strategic foundations in achieving long-term success with clinical data technologies.
“As biopharma continues to struggle to meaningfully solve key challenges that have plagued the industry for years—including accelerating cycle times and boosting research and development productivity—only 26% of respondents are very satisfied with the speed at which their organizations are innovating their data strategies and processes,” said Indupuri. “AI can support the industry in driving tomorrow’s breakthroughs, but to do so, organizations must establish an interoperable data and analytics infrastructure, creating a strong, well-designed foundation that empowers innovation.”
This sentiment reflects a broader industry realization: that sustainable innovation is not about implementing every new tool available, but about creating an environment where technology can thrive in harmony with organizational goals, regulatory requirements, and human expertise.
The Role of Strategic Partnerships in Digital Transformation
In addition to internal infrastructure and process improvements, the 2025 Industry Outlook highlights the critical role of external partnerships in achieving digital transformation in clinical data management. A substantial 75% of respondents reported working with outsourcing partners to manage aspects of their clinical trial data. However, many of these partnerships appear to fall short of expectations.
Survey data shows widespread dissatisfaction with outsourcing performance in key areas. Among the top concerns: partners’ ability to meet clinical data timelines, provide experienced professionals, and deliver consistent, high-quality outputs. These shortfalls point to a misalignment between the increasing complexity of clinical trial data and the current capabilities of many service providers.
Diane Lacroix, Vice President of Clinical Data Management at eClinical Solutions, noted that there is clear room for improvement in how outsourcing partners contribute to data strategy.
“The data is showing over 80% of industry leaders want their partner to do better at providing them with real-time data insights, and 81% want their partner to do better at proposing innovative solutions,” said Lacroix. “As life science organizations continue to face data chaos problems, choosing vendors that are transforming data delivery with a focus on people, processes, and technology will ensure improved efficiencies when handling more complex trial designs and emerging data types.”
The call to action is clear: future-ready organizations must not only invest in the right technologies, but also align with partners who can complement internal capabilities with innovation, responsiveness, and strategic insight.
A Future Defined by Strategic Focus
The eClinical Solutions 2025 Industry Outlook paints a realistic and forward-thinking picture of where clinical data management is headed. While the initial hype surrounding AI is beginning to normalize, the technology remains a cornerstone of future transformation—provided it is deployed thoughtfully, with clear goals, supportive processes, and a strong technical foundation.
Simultaneously, the rise of risk-based strategies and the growing demand for real-time insights reflect a shift toward more practical, results-driven approaches to trial optimization. Add to this the increased scrutiny of outsourcing partnerships, and the picture becomes even clearer: life sciences organizations are not just seeking new tools, but a new way of working that brings together technology, talent, and teamwork to deliver smarter, faster, and more reliable clinical research outcomes.
As the industry continues to evolve in response to growing trial complexity, regulatory pressures, and patient-centric demands, organizations that can balance innovation with strategic execution will be best positioned to lead the next wave of transformation in clinical development.
