Reimagining clinical programming

Clinical development is entering a new era. Sponsors are facing increasing complexity in trial design, tighter timelines, and growing demands for cost effectiveness, speed, transparency and reproducibility.

At the same time, the tools used to support statistical analysis and programming are evolving. Among these, the adoption of R is emerging as a strategic priority.

R is not simply a programming language. It represents a shift in how the industry approaches data, collaboration, and innovation. Its open-source foundation enables flexibility, reproducibility, and community-driven development. These qualities are becoming essential as sponsors seek to modernise their clinical trial infrastructure.

The industry is moving forward

Across the pharmaceutical and biotech sectors, the use of R is steadily expanding. Sponsors are exploring its potential for exploratory analyses, quality checks, and full regulatory submissions.

Historically, organisations developed proprietary tools to address common challenges such as cost, speed, standardisation, and quality. Open-source changes this dynamic. Companies are now working together to build shared solutions that reduce duplication and improve overall quality. Initiatives like Pharmaverse exemplify this shift, offering curated packages for ADaM, SDTM, and TFL workflows¹ that promote consistency and streamline reporting.

The move to open-source also removes the constraints of traditional licensing models, enabling scalability across teams and studies. More importantly, it empowers users to design tools that meet their specific needs, fostering innovation where generic solutions often fall short.

Adoption, however, varies. While some organisations are fully embracing R, others are taking incremental steps through hybrid models or pilot programs¹. The key question is no longer whether to adopt R, but how to do so in a way that aligns with broader strategic goals.

The shift towards R should not be viewed merely as a technological switch. It reflects a broader cultural transformation that encourages collaboration and co-creation. It is about creating systems that are agile, transparent, and capable of supporting the demands of modern trials.

R is a powerful enabler of this change. Its success will depend on how it is adopted, scaled, and integrated into strategic workflows. For sponsors, the opportunity lies in approaching R not just as a tool, but as a catalyst for transformation.

R adoption requires more than code

Despite its advantages, adopting R at scale is not trivial. It requires infrastructure that supports reproducible workflows, training that builds internal capability, and governance that ensures compliance. Sponsors must consider how R fits into their broader data strategy, how it interacts with existing systems, and how it can be scaled across studies and teams.

This is where strategic partnerships become essential. The most successful transitions are not driven by tools alone, but by a clear vision for how programming can support faster insights, better decisions, and more efficient submissions.

ICON’s approach to R adoption

ICON supports sponsors in transitioning to R with confidence. Our Biostatistics and Programming team integrates R into clinical workflows to deliver scalable, reproducible, and interactive solutions. We combine R with SAS in a hybrid framework, enabling dynamic reporting through RMarkdown and interactive data exploration via Shiny.

Our proprietary platforms are designed to streamline programming, reduce manual effort, and ensure consistency across studies, and our R training environment enables rapid team scaling, reflecting our commitment to consistent delivery and effective change management. ICON’s approach is not just technical. It is strategic. We help sponsors align R adoption with their broader goals for innovation, compliance, and operational efficiency.

Partner with ICON to unlock the full potential of R in your clinical development programs.

Contact us today or visit ICONplc.com/biostats to learn more about our comprehensive biostatistics and programming solutions.

References:

Knoph, A. & Farrugia, R. (2024). How R Pharma? An overview of industry adoption of R programming in clinical reporting. Presented at PHUSE EU Connect. Summary available via Pharmaverse: https://pharmaverse.org

The industry is moving forward

R adoption requires more than code

ICON’s approach to R adoption

Partner with ICON to unlock the full potential of R in your clinical development programs.

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