Where monitoring models are heading: interpreting the latest Tufts data
The way we approach and monitor clinical trial data is changing. The prescriptive, one-size-fits-all method of 100% source data verification (SDV) and 100% source document review (SDR) is unwieldy for larger and more complex trials. More to the point, it can be inefficient or outright unfeasible depending on a number of study and operational factors. More centralised and risk-based approaches to clinical monitoring are gaining traction across the industry, with regulators and sponsors of all sizes.
According to 2026 Tufts CSDD survey data1, as much as 75% of large sponsors and 51% of small sponsors are fully or partially implementing central and risk-based monitoring. ICON found similar results in our 2025 industry survey of 132 biopharmaceutical sponsors aimed to capture changing expectations around CRAs and monitoring models: most sponsors are already moving away from traditional monitoring (100% SDV/SDR) in favour of more efficient methods2.
Here, we explore the Tufts survey data alongside our own survey data to interpret emerging patterns in monitoring models and understand how they are evolving as the industry matures.
Adoption patterns across large, midsize and smaller sponsors
ICON and Tufts data both reflect increased adoption of RBQM. Risk-based monitoring, either in full RBM or hybrid models, is already in practice for most survey respondents across all sponsor types. This increase can be partly attributed to the regulatory support, namely with ICH GCP E6(R3)’s emphasis on risk‑based, risk‑proportionate oversight and a stronger role for continuous central and remote monitoring. The guideline, published in 2025, supports a model in which central review operates across the entire study lifecycle, with onsite activity introduced proportionately based on risk levels and pre-identified critical to quality (CtQ) factors.
While some sponsors have fully mature centralised and RBM models, many sponsors are still transitioning. Tufts survey data shows that 43% of their respondents are currently in partial implementation or piloting phases. Looking at Tufts data, we see that large pharma is more likely to use centralised, remote or RBM methods than smaller sponsors. Large pharma has the scale, data infrastructure and regulatory experience to justify upfront investment and consistently realise efficiency and compliance gains across large, complex trial portfolios.
Comparatively, data from ACRO shows that midsize sponsors have the highest adoption rates of RBQM components and are more likely to outsource risk assessments.3 Midsize sponsors are at the threshold where they face strong cost and speed pressure to scale programs like large pharma while lacking the internal resources and headcount for traditional onsite monitoring. Centralised, remote and RBM methods are the most practical way to compete efficiently. The risk assessment and the early identification of CtQ factors is part of a regulatory-approved approach. It’s also crucial to determining the right monitoring strategy for each study to ensure optimal outcomes.
Understanding monitoring model options
While Tufts combined risk-based and central monitoring models in their survey, our 2025 survey separated risk-based, central/remote and hybrid models as alternatives to traditional monitoring to capture a more nuanced view of uptake and implementation given that these models and their terminologies are evolving.
Traditional monitoring methods are intensive. They rely on CRAs to deliver 100% SDV/SDR across every site in their study which takes a lot of time and resources without proven data quality benefits. Modern trials collect more data, with data coming from a wider array of channels, and there are global CRA staffing constraints that, together, make traditional monitoring across the board unfeasible. Risk-based monitoring, centralised monitoring, and hybrid models allow monitors to optimise efforts to reach quality and efficiency goals while maintaining data integrity and quality.
In our 2025 survey, we found that hybrid models are gaining popularity as sponsors are blending elements of central, remote and onsite monitoring to suit the unique operational needs of their clinical trial. The popularity of hybrid approaches signals a strategic approach from sponsors and reflects the increased attention to optimising early design for downstream efficiencies. In other words, sponsors aren’t just switching away from traditional monitoring, they are actively adapting new methods to fit key aspects of their clinical trials. Aspects like therapeutic profile, risk tolerance, geography, site and participant landscape, and monitoring preferences all play a role in determining the best model.
ICH GCP E6(R3) requires monitoring plans be built around CtQ factors; the specific participant safety and data quality risks, and any other risks that could jeopardise reliability of trial results. Identifying CtQ factors early enables a flexible, scalable, clinical trial-specific strategy that can be tailored to the sponsor’s risk tolerance and their point on the RBM adoption journey.
As sponsors explore the models and components available to them, and as regulatory bodies demonstrate acceptance of data from different monitoring models, we expect these adoption numbers to grow as sponsors become more confident.
RBQM and redistribution of monitoring efforts
There is a lingering misconception that remote, centralised or risk-based models mean less monitoring. RBM and risk-based quality management (RBQM) strategies use insights and Quality by Design (QbD) principles to efficiently redistribute monitoring efforts, not reduce them. The Tufts survey data demonstrates this in part, wherein sponsors and CRAs are reporting fewer, more targeted onsite visits for low-risk sites while visiting high-risk sites more frequently and for longer duration (Figure 1 below). CRA time saved from low-risk sites is reinvested into monitoring of high-risk sites.
When shifting away from 100% SDV/SDR, remote CRAs and central teams absorb a greater proportion of oversight activity. The allocation of CRA time spent at low vs high-risk sites is guided by central monitors that may assess trends, run analytics, identify anomalies and evaluate risk signals that can trigger more targeted follow up when needed. This approach to risk-based monitoring does not mean less monitoring, it means smarter allocation of CRA and central resources based on data driven risk signals so that oversight intensity matches site risk.
Onsite monitoring involves a CRA visiting the investigative site in person to review source records, confirm data accuracy, assess site processes and build relationships with site staff. It remains an essential component of trial conduct for activities that require physical verification or direct interaction. Time onsite can also be used to build site relationships, discuss enrollment strategies, or revisit protocol expectations.
Offsite monitoring refers to CRA activities conducted away from the site, typically from a home office or regional location. It includes two distinct types of visits:
- Offsite visits with remote SDV/SDR
The CRA reviews electronic source documents electronically, completes targeted SDV or SDR tasks and evaluates all data remotely. This approach supports reduced onsite burden while maintaining oversight of critical data. - Offsite visits without SDV/SDR
These visits could focus on a plethora of different topics, e.g., reviewing/collecting study documentation, following up on overdue or action items, preparing sites for upcoming visits, discussing enrolment challenges, or addressing operational or logistical issues. They complement onsite visits and rely on central monitoring or data aggregate outputs to guide priorities.
Managing successful RBQM adoption
Narratives around progress are often framed as linear. Clinical research is far more complex than that. The adoption of RBQM is progress, but the data indicates that success relies heavily on the consistency and usability of systems. Tufts reports that roughly one third of sponsors still rely on in‑house or homegrown central monitoring systems. These systems can work for specialist groups with sophisticated analytics functions but are often too complex and resource‑heavy for most non‑specialist sponsor teams to maintain. As central monitoring responsibilities scale and analytic needs grow, we expect a decrease in the use of homegrown systems with sponsors outsourcing to CROs with configurable platforms that reduce maintenance burden and standardise workflows.
Making RBM model decisions
Breaking away from fully traditional RBM models brings improvements in key indicators, as reported in the Tufts survey and supported by the practical experiences of CRAs, sponsors and subject matter experts. Depending on the study, the systems, training and culture, the changes required to realise these benefits can potentially cause disruption. But the organisations that interpret these trends thoughtfully and invest in the people, systems and shared understanding needed to support them will be best positioned for the next phase of monitoring evolution.
Selecting the right monitoring model for your clinical trial requires thorough assessment of size, phase, and therapeutic area layered with CtQ and risk factors. ICON has developed a flexible model solution built to align with sponsor goals and risk profile, with the ability to adapt to specific clinical trial requirements and meet sponsors wherever they are in their RBM/RBQM and centralised monitoring journey.
Explore different monitoring models, including risk-based, hybrid, central and remote monitoring, and their critical to quality factors in our whitepaper, More than monitoring: How modern monitoring paradigms impact CRA roles.
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References
1. Tufts CSDD Impact Report. Volume 28, Number 1. January/February 2026. Accessed 16 April 2026.
2. ICON plc. More than monitoring: How modern monitoring paradigms impact CRA roles. Published 2025. Accessed 16 April 2026. https://www.iconplc.com/insights/transforming-trials/more-monitoring
3. Association of Clinical Research Organizations (ACRO). RBQM Summary Report. Published 2025. Accessed 16 April 2026. https://www.acrohealth.org/rbqm-summary-report/