Transforming central labs with automation and AI: setting new standards for modern trials

Clinical trials are evolving rapidly. Protocols are more complex, amendments more frequent and data demands are both more intense and more diversified. For central laboratories, this shift heightens the challenges around speed and agility in an environment that demands excellence in execution with the highest standard of scientific integrity.

ICON Laboratories is meeting this challenge with a bold transformation strategy that combines intelligent operational redesign, automation and AI-enabled innovation. The result is a modernised lab model that keeps pace with today’s trial needs and offers a compelling, scalable blueprint for future expectations.

Challenge #1 – The complexity challenge

Central labs sit at the heart of clinical trial execution, responsible for managing lab testing, rapid data outputs, logistics and site support across global studies. Traditional lab operations are straining under the weight of these modern protocol designs that multiply the challenge of rapid delivery.  

Studies now include more endpoints, procedures and amendments than ever before.  In the past ten years, the number of data endpoints in clinical trials has doubled – many of which are laboratory biomarkers – thus furthering the challenge for labs to provide streamlined and rapid processes in a fast evolving environment. Nearly three-quarters of protocols require at least one major amendment, with many undergoing multiple amendments in their lifetime. Central labs are often expected to “deliver” even when last-minute protocol changes occur – and these must be rapidly executed to ensure readiness for site and patient activities.

Regulatory compliance requirements are also intensifying for laboratories, driven by global shifts like the EU’s transition from the In Vitro Diagnostic Directive (IVDD) to the more rigorous In Vitro Diagnostic Regulation (IVDR), which demands stricter compliance for diagnostic assays. In the US, a recent court ruling overturned attempts to regulate laboratory developed tests (LDTs), reaffirming Clinical Laboratory Improvement Amendments (CLIA) oversight but leaving future regulatory direction uncertain. These changes highlight the need for labs to stay agile and adapt quickly to evolving standards, particularly as it pertains to assay selection and study setup processes for labs.

Challenge #2 – The resourcing challenge

One of the most persistent pain points in central lab operations has been project management resourcing. Historically, lab project manager (PM) workloads were managed under models that used estimated averages. However, simple averages of workload fail to account for variance in study complexity, which leads to overburdened teams and inconsistent service delivery. This model has been in play for a long time in central labs, but it does not meet the needs associated with growing protocol complexity, increasing scale and the global nature of today’s trials. Working in this model leads to PM burnout and increased attrition rates, losing valuable expertise from labs amid important trials. 

ICON Laboratories Solutions

ICON’s solution to the outdated central lab resourcing approach is a proprietary Resource Management Tool (RMT) based on full-time equivalent (FTE) modelling. This system allocates lab PM hours according to study complexity and shares those allocations transparently with sponsors for a clearer, more predictable model.

The impact has been immediate and measurable. ICON Laboratories clients are embracing our new solution where:

• sponsors gain clarity on expected service levels, including meeting cadence and reporting
• PMs benefit from balanced workloads, avoiding burnout and improving retention
• milestone achievement rates have increased, in particular relating to managing protocol amendments which involve unexpected peaks in PM demand
• client satisfaction has risen by >15 percent year on year.

This shift from opaque estimation to transparent modelling has redefined how central labs engage with sponsors, fostering deeper trust through accountability.

Automated, accelerated study builds now 40 percent faster

Study startup for labs is rife with its own unique challenges, and this is another key area where ICON has made significant investments in solutions. ICON Laboratories addresses challenges in this phase with a suite of automated solutions that streamline database design and configuration.

The launch of SOLAR in 2022 replaced manual, paper-based workflows with a digital platform to reduce operational burden and accelerate startup time. Our latest enhancement in 2024 enables direct import from SOLAR to ICON’s laboratory information management system (ICOLIMS), which has significantly accelerated database build timelines – now achievable in five weeks or less.

Since mid-2024, ICON has deployed this automation across over 100 studies. The results prove a consistent 40 percent reduction in cycle time for study setup and for protocol amendment implementation, while improved quality is also evident via reduced manual effort.

In turn, sponsors benefit from quicker site initiation visits and more agile trial maintenance. ICON’s teams gain efficiency and scalability, enabling parallel delivery of lab kits, budget change orders and other critical startup components.

AI-driven protocol digitalisation

ICON’s AI Centre of Excellence is pioneering a new future in clinical trial operations. In a lab’s application, an intelligent agent reads trial protocols, extracts relevant data and auto-generates study documentation and system specifications. This innovation, currently in pilot phase, is already showing strong results in improving study startup speed and quality.

By digitalising protocols and automating documentation, ICON is reducing the time and effort required to launch new studies. This not only accelerates timelines but also enhances consistency and reduces the risk of human error. As trials become more adaptive and data-driven, AI solutions will play a critical role in maintaining pace and precision.

Proven success and future vision

ICON’s transformational approach has incorporated innovation with promising proof points. In post-automation studies, 66 percent of lab databases were built within an eight-week timeline, compared to just 46 percent before automation. ICON more than tripled the proportion of studies completed in five weeks or less and reduced amendment timelines to as little as 3-5 days.

These improvements enable faster site readiness, more responsive trial maintenance and better forecasting for supplies and budget changes.

Looking ahead, ICON will continue to roll out enhancements to SOLAR and ICOLIMS, expand AI integration under the guidance of our dedicated AI Centre of Excellence and explore new automation opportunities to solve real-world pain points for all stakeholders.

Setting a new standard for central labs

ICON Laboratories is redefining what central labs can achieve – and how efficiently it can be achieved. By acknowledging the complexity challenge within clinical trials and responding with innovation, ICON is delivering faster, more reliable and more transparent services to sponsors and study teams alike.

ICON’s approach offers a clear path forward, balancing speed with scientific rigour and operational excellence with tactical, intelligent solutions. For sponsors seeking a partner that understands the pressures of modern clinical research and has the tools to meet them, ICON Laboratories is a trusted partner in meeting modern clinical trial needs.