Commentary
Rethinking Quality in Clinical Trials
Jim Kremidas
Association for Multisite Research Corporations (AMRC)
H

ow many times have we heard that there’s a ceiling to the speed of clinical trial delivery? “Move too fast, and we put the fundamentals at risk.”

Now, the concern isn’t about speed per se. Fast, reliable studies are the goal many of us are chasing. The “objections to speed” center on how well trials can be executed at pace: whether sites follow protocol, whether patients are appropriately assessed, and whether data can support confident decisions. Speed is valued, but not at the expense of quality.

Recent analysis suggests that performance doesn’t have to be negatively correlated with speed. If trial performance is supported at an operational level by infrastructure and training, high-quality trials can be delivered safely, consistently, and quickly.

Evidence from Operational Performance

An analysis conducted by the Association for Multisite Research Corporations (AMRC), in partnership with an unnamed top-five pharmaceutical company, compared the performance of multisite clinical research corporations (MCRCs) to that of other site types.

AMRC defines MCRCs as site networks operating at scale, comprising at least five sites and with a primary commercial focus on clinical trial delivery. The assessment looked at US-based trials, comparing the performance of AMRC member sites (MCRCs) to all other site types used in the studies.

The data showed that MCRC sites moved from Final Protocol to Site Ready 65 days faster than other site models. The transition from Site Ready to first subject in (FSI) was also shorter, at 57 days compared with 87 days.

Two side-by-side box plots comparing AMRC and Non AMRC across two metrics: "Final Protocol to Site Ready" and "Site Ready to First Subject In." In both charts, the AMRC group shows lower median values and shorter ranges.
Figure 1: Cycle time analysis, AMRC sites versus non-AMRC sites. Note: “Non-AMRC sites” is a proxy for all non-MCRC site types.
The traditional assumption would be that this increased speed was accompanied by increased risk to quality. Yet, the proportion of important protocol deviations relative to total deviations was slightly lower for MCRC sites, at 13.3% compared with 14.7% for other sites. Query performance and data entry timelines were comparable across both groups, while MCRC sites showed less variation in cycle times and a lower proportion of nonenrolling sites.
Three charts comparing AMRC vs. Non AMRC: box plots for "Deviations per Subject" and "Important Deviations per Subject," and a bar chart showing "% Important Deviations" (13.3% for AMRC vs. 14.7% for Non AMRC).
Figure 2: Deviation analysis, AMRC sites versus non-AMRC sites. While the average number was similar between the two, AMRC sites demonstrated less variability.
Far from suggesting that speed is achieved at the expense of quality, these data point to a model in which both improve together.

Quality as a System-Level Outcome

In October 2025, AMRC released proprietary research that showed MCRCs performed among the best of the site models on the measures that sponsors and CROs say they value most: speed, consistency, and efficiency. MCRCs were particularly associated with greater consistency, faster start up, scalable infrastructure, and access to diverse patient populations—arguably the most important factors in site selection.

Horizontal bar chart titled "Site type experience" showing 88% for Academic Medical Centres and Independent Sites, and approximately 77% for MCRCs and Community Networks.
Figure 3: Sponsor and CRO experience working with different site types, based on a survey of 44 senior to midlevel respondents from CRO, biotech, pharmaceutical, and other organizations, commissioned by AMRC. 92% of respondents were involved in site selection.
Despite this, decision-makers expressed a preference for other site models, largely because they were perceived to represent higher “quality,” even when they rated lower on individual performance measures. While those with direct experience of MCRCs rated them as “good,” very few described them as “excellent.”
Table titled "% Selecting MCRC as Best" by attribute. Top responses include Ability to Scale (60%) and Centralized Processing (56%). Other attributes like Site Locations and Document Management range from 46% down to 38%.
Table 1: Percentage of 42 respondents from CRO, biotech, pharmaceutical, and other organizations who rated MCRCs as best in class (highest ranked attributes).
To understand this, AMRC conducted an industry consultation at the end of 2025, asking sponsors, CROs, multisite organizations (both members and nonmembers), and operational and quality leaders to share their thoughts on the topic.

In the consultation, site respondents all attributed performance to the environment in which trials are delivered, placing importance on stable teams, clear processes, and defined ways of working. They saw operational indicators such as protocol deviations, query timelines, enrollment accuracy, and stable teams as the most reliable signals of quality.

Table showing "Site Type" survey responses: AMC (29%), MCRC (26%), Independent (13%), Community (5%), and "Don't know / No difference" (27%).
Table 2: Percentage of 585 performance assessments in which each site type was rated highest performing across 23 operational and site attribute areas, based on a survey of 44 senior to midlevel respondents from CRO, biotech, pharmaceutical, and other organizations commissioned by AMRC.
Table showing quality indicators. Metrics like stable teams, SOPs, and deviation rates are rated "Most reliable indicator," while investigator credentials, training completions, and institutional reputation are rated "Poor standalone proxy."
Tabel 3: Key performance quality indicators identified through AMRC’s industry consultation (November 2025), based on responses from MCRC leaders, operational and quality specialists, and industry body representatives.
Input from sponsors and CROs corresponded with the original research (published in October 2025): While there was broad agreement on the importance of these metrics, quality was still often inferred through traditional measures, such as institutional reputation or investigator experience. This highlights a clear gap in how performance is experienced at a site level and how it is interpreted in selection and oversight decisions.

The most obvious example of this is the value placed on individual Principal Investigators (PIs), with sites arguing that site selection teams place too much relevance on individual PI resumes, while sponsors and CROs cite PI experience as key measures.

Table comparing AMC, MCRC, Independent, and Community site types across four experience attributes. AMC scores highest in all categories, notably in Investigator Experience (Operations) at 65% and Therapeutic Area Experience at 64%.
Table 4: Percentage of respondents selecting each site type as best-in-class for experience-related attributes, based on a survey of 44 senior to midlevel respondents from CRO, biotech, pharmaceutical, and other organizations commissioned by AMRC.
Table of quality indicators. Metrics like stable teams and SOPs are rated "Most reliable signal of quality," while investigator credentials, training completions, and institutional reputation are rated "Poor standalone proxy for quality."
Table 5: Quality indicators identified through AMRC’s industry consultation (November 2025), based on responses from MCRC leaders, operational and quality specialists, and industry body representatives with experience spanning sponsors, CROs, and sites.
It’s wrong to link performance to a single individual. Clinical research is a team sport and depends just as strongly on the support PIs receive. MCRCs typically have centralized processes, training, and administrative support; they cultivate “career PIs”—specialists dedicated to clinical research—and an environment that encourages stability. Across the AMRC network, PI turnover is just 7.8% and CRC turnover is 15.4%, compared to industry averages of 54.2% and 33%, respectively. This level of continuity provides a more stable foundation for delivery than is often assumed and challenges the idea that experience sits primarily outside of network models.

Questions of quality are often framed around personal experience or ownership models. In practice, they come down to consistency of execution and accountability. Trial providers that cannot deliver reliable outcomes cannot expect to sustain long-term partnerships, regardless of how they are structured.

Why System-Based Delivery Changes Outcomes

The systems that exist in MCRCs don’t just benefit PIs. The performance advantages observed in the MCRC comparison with other site types reflect the infrastructure common to these networks.

Centralized processes change how studies are delivered in practice. Start-up, recruitment, and performance management are coordinated across a network, rather than handled in isolation, with shared data, clear targets, and specialist oversight.

This tends to remove variation and is reflected in shortened timelines and how quickly deviations are spotted and addressed. The shorter cycle times in the comparison data are a result of a more controlled method for delivering trials, not sites pushing themselves to a breaking point to move faster.

Rethinking Definition of Quality

This analysis highlights how out of step quality measures are with how they’re expressed in delivery. MCRC sites can deliver more quickly while maintaining comparable and, in some areas, slightly stronger operational outcomes. Yet, these differences are not always reflected in how sites are evaluated.

In practice, site selection always involves a balance of speed, quality, and cost. Investment can accelerate timelines, but only when it is directed toward the factors that actually influence delivery, such as start-up time, patient recruitment and retention, minimal deviations, and fast query resolution.

Reassessing how quality is defined and measured is a practical next step for our industry. A move away from proxy indicators, such as PI experience, toward performance measures that demonstrate how a trial is delivered will not only speed up clinical trials but will also support greater consistency and more informed decision-making for site selection teams.

MCRCs have shown that a systematic approach to delivery, supported by the right infrastructure and operating models, can improve how trials are executed. The result is faster, more consistent delivery that supports the quality outcomes Sponsors and CROs ultimately depend on.