May 2026 • PharmaTimes Magazine • 38

// AI //


Human racing

The modernisation imperative in clinical data analysis and regulatory submission

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In life sciences, delays in clinical development have real consequences.

Patients are waiting for therapies that could extend or improve their lives. Every delay has real consequences – not just for organisations but for patients and the progress of science itself.

Yet there are still avoidable delays, many of which stem from outdated IT infrastructure that is ill-equipped for the complexity of drug development and delivery today.

Clinical teams are often well aware of the limitations of legacy systems. Slow and clunky, the technology has not kept pace with multi-stakeholder collaboration, nor can it process the bigger and more diverse data sets from decentralised and hybrid trials and real-world and biomarker data.

Studies suggest that data points collected in phase 3 protocols quadrupled between 2012 and 2020 – a figure that will have grown further since and will continue to do so as our data capture capabilities grow.

We have reached a tipping point where organisations can no longer innovate safely at speed without a modern analytics environment.

Speed, scalability, compliance

To address these challenges, organisations are increasingly turning to modern, cloud-native analytics platforms.

A validated, cloud-native platform gives teams the speed and scalability to innovate, allowing them to deploy AI and machine learning models and remove limitations on current data processing capabilities.

However, speed in clinical development is often perceived to be at odds with compliance.

The speed these platforms offer does not compromise compliance – in fact, it strengthens it. Emerging capabilities such as agentic AI can autonomously detect protocol deviations, helping to de-risk the complex clinical trials process.

A modern analytics environment is designed to promote confidence in regulatory submissions by supporting clear audit trails, data traceability, role-based access and adherence to CDISC standards.

By reducing manual processes and improving transparency, these capabilities enable faster, more confident submissions rather than slowing them down.

Despite these advantages, acknowledging the limitations of legacy systems is one thing but nervousness about upending existing software and data migration remains a barrier to innovation.

Operationally, it is seen as a risky and resource-intensive task, where data quality, integrity and traceability must be maintained and any downtime minimised.

While this perception persists, the greater risk now lies in maintaining environments that cannot support the demands of modern clinical development.

But modern migration projects do not need to be fraught with challenges. With the right platform, it is possible to simplify the process while improving data quality and governance.

Once implemented, a modern platform provides a central global repository for teams to access data, which supports collaboration and best practices and reduces duplication.

Barriers between sponsors, CROs and regulatory bodies are broken down, while no-code/low-code capabilities empower teams to create their own AI models within strictly governed frameworks, further driving innovation.

Its open architecture and readiness for AI and machine learning, including emerging capabilities such as AI agents and copilots, allow organisations to scale innovation in a controlled and compliant way.

Modernisation is non-negotiable

The question is no longer whether to modernise but how to do so responsibly, at speed and at scale.

Most cloud-native analytics platforms are scalable, user-friendly and collaborative by design, especially compared to outdated proprietary systems. That alone can improve data analysis and develop efficient processes for regulatory submission.

However, what is critical in life sciences is that this architecture comes with an inbuilt data governance framework that not only promotes but enforces best practices. When these foundations are in place, speed is no longer a trade-off – it becomes an inevitable outcome of better systems.


Patrick Homer is Advisory Life Sciences Leader at SAS

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