Benchmarking the Investigative Site Qualification Process
Insights identify opportunities to optimize sponsor, CRO, and site collaborations.
Project Manager, Senior Research Consultant
Assistant Director, Data Sciences and Analytics
This article presents the results of a recent study—to our knowledge the first of its kind—to benchmark the clinical trial site qualification process (feasibility, qualification visit leading to site selection). The study results are remarkable and offer sites new insights into ways to strengthen their ability to secure study grants. The results also offer sponsors and contract research organizations (CROs) new insights into optimizing their partnerships with sites.
Based on our research, we estimate that the global investigative site community spent $170 million in 2024 to complete feasibility assessments and site qualification visits for FDA regulated industry-funded clinical trials. This staggering investment is required to support a steady pipeline of activity and translates to 2,500 hours, on average, each year per investigative site that are dedicated to these processes.
Investigative sites are selected for two-thirds of the studies—on average—to which they were invited to bid, though this win rate varies widely by investigative site type. Sites are asked to re-bid on approximately 15% of the studies that they initially lose.
Investigative site survey respondents indicated that the top areas that would improve the feasibility process include providing a full protocol versus a protocol synopsis and pre-populating the feasibility questionnaire with historical site information to promote focus on study-specific areas of the feasibility assessment. Our analysis of the results also found a strong positive association between win rates and principal investigator (PI) and study coordinator involvement in the feasibility and selection process.
Some background about this study: The Tufts Center for the Study of Drug Development (Tufts CSDD) convened a working group of 16 sponsor companies and CROs to help shape a comprehensive study looking at the global vendor qualification process. This included assessments of contract clinical research, specialty services, technology vendors, and study conduct service providers (or investigative site). The working group provided funding for the study as well as input into survey designs.
The survey among investigative sites centered on several key areas, including the efficiency and scope of feasibility assessments and qualification, along with the time investment and the resources required for these processes.
The survey was conducted between April and July 2024. Investigative sites were identified and contacted using ClinicalTrials.gov. Responses were collected electronically through Qualtrics. In parallel, Tufts CSDD gathered salary information on site personnel from various commercial sources such as Indeed, Glassdoor, LinkedIn, and Zip Recruiter. This data included information on salary ranges, health and life insurance benefits, and other areas contributing to overall personnel compensation This information was used to estimate fully loaded salaries for personnel, and then applied to annual work-hour estimates to derive total annual spend on site feasibility and qualification activities.
Raw data was stored in Microsoft Excel for initial review and organization. Data cleaning and analysis were performed using SAS version 9.4, where variables were processed, and statistical analyses performed (e.g., descriptive statistics, frequency comparisons, coefficients of variation, analysis of mean response values, subgroup stratification, and significance testing).
Respondent characteristics
Nearly 300 (n=290) responses were received from a broad range of site types, sizes, and locations as outlined in Table 1 (see below). Respondents from academic medical centers (AMCs) represented the largest cohort, but good representation was obtained by independent or community-based sites and site networks/site management organizations (SMOs). Respondents were asked to indicate the total number of employees in their organizations. This was used to segment the sites into small, mid-size, and large size tertiles. Half of the respondents were from North America and nearly 30% from Europe.
Key findings
Annual global investment of time and cost to support feasibility and qualification.
On average, sites spend nearly 2,500 hours each year to support the qualification process. The work effort varies significantly by site type due to differences in capacity and infrastructure; level of experience; and volume and type of patients served—all areas that drive annual clinical trial volume. AMCs invest approximately 4,500 hours to these processes each year; SMOs invest, on average, 900 hours; and independent sites invest an average of 280 hours. Figure 1 (see below) summarizes average annual time spent by broad investigative site type.
Tufts CSDD converted time investment into financial investment based on personnel compensation levels.Using FDA’s BioResearch Monitoring Information System (the BMIS dataset of 1572 filings), Tufts CSDD estimates that the global investigative site community spent a total of $170 million to qualify for FDA regulated industry-funded clinical trials in 2024.
Table 2 (see below) provides a more granular view of the cost per assessment by investigative site type. The median costs and the interquartile range (IQR) convey the wide variation observed within each site segment. The IQR, which is a measure of variability, shows the spread of the middle half of a dataset. It is the differences between the 75th and 25th percentiles of a dataset. As Table 2 shows, overall, the median annual financial investment to support feasibility assessments and site qualification visits is nearly $7,500.
Variation in the total investment are due to many factors, including personnel compensation levels as well as the typical personnel by site type participating in the process.
Figure 2 (see below) presents the median number of feasibility assessments a given site performs each year. Looking at all site segments combined, on average, 15 feasibility assessment and 10 qualification visits are performed annually. Site networks/SMOs perform double the typical number of feasibility assessments compared to the other site types.
Overall, the full feasibility assessment process takes, on average, approximately one month (29.4 days). Investigative sites take a little more than a week to complete the feasibility assessment or questionnaire. Sites then wait nearly three times longer to receive a response from the sponsor or CRO. Wide variation by site type is again observed here. Site Networks and SMOs complete the process much faster than do AMCs. But site speed and efficiency in managing the feasibility assessment process is essentially lost due to the time that all sites must wait for a response from the sponsor or CRO.
A similar pattern can be seen in site qualification visits. The process overall takes approximately one month (31.1 days). Preparing for and conducting the site visit takes nine days, on average, and 23 days to receive a response following the visit. AMCs spend nearly twice the amount of time than other sites. And investigative sites with dedicated feasibility assessment teams are able to complete this process in two-thirds the average time. Nonetheless, speed and efficiency gains are lost due to the wait time to receive a response from the sponsor or CRO (see Figure 3).
Win rates and the factors impacting them
Investigative sites report that they are selected for two-thirds of the studies to which they initially bid. In addition, respondents indicated that they are asked to submit re-bids on one in seven (or 14%) of the studies that they initially lost.
Site type is associated with win rates (see Figure 4 below). Site networks invest proportionately more in the qualification process than do other site types, yet have a lower win rate. Conversely, AMCs spend less, yet have a much higher win rate. This is due to many factors, including the unique expertise and patient populations found in AMCs.
Multiple functions are involved in the site qualification process depending on the size of the investigative site. Some organizations have dedicated feasibility and business development teams, whereas other sites rely primarily on the PI and clinical research coordinator (CRC) to complete the feasibility assessments and participate in the qualification visit. Not surprisingly, the highest percentage (71%) of site networks and SMOs have a dedicated team supporting the process. Only 27% of AMCs have a dedicated team. The majority relies predominantly on the PI and the CRC.Independent sites use a mix of staff and functions.
Although conventional business wisdom would suggest that specialized, dedicated qualification teams are associated with higher win rates, the opposite is true. PI and study coordinator participation in the feasibility through selection process is predictive of higher win rates overall and by individual site type (p<.0001).
Although sites with dedicated teams (most notably site networks/SMOs), may not win more studies based on having a dedicated team, they are asked for follow-up information less often (only 21% of the time), suggesting that they offer a more efficient process. Independent sites and AMCs are asked for follow-up information on approximately half of the feasibility questionnaires that they complete.
Lastly, following completion of the qualification process, investigative sites report that they receive feedback from sponsors and CROs on less than half (43%) of assessments. And when it was provided, 51% of sites indicated that the feedback was generally not useful or helpful.
Notable trends
The vast majority (80%) of investigative sites report that, compared to three years ago, it is taking more or about the same amount of time to complete feasibility assessments. And nearly half of sites indicate that the feasibility questionnaire is easy or very easy to complete. Half of sites (48%) believe that the feasibility assessment process is less demanding than it was compared to three years ago.
Survey respondents identified a number of factors that are influencing the process. Table 3 (see below) summarizes these factors. Some fall outside of the sites’ control and present opportunities for sponsors and CROs to improve the process. In other cases, sites have worked to streamline their workflows, build out internal process and SOPs, and created feasibility teams as ways to make the process more efficient.
Despite anecdotal historical reports, the majority of investigative sites perceive no difference in the overall burden and the nature of the questions in the feasibility assessment processes when managed by the sponsors or a CRO. Nearly two-thirds (64%) of sites indicate that there is no difference between the two. Approximately 10% report that the sponsors’ process is relatively more burdensome.
In our survey, investigative sites provided feedback on ways that sponsors and CROs can improve the feasibility and site qualification processes Three broad areas were identified: information gathering, sharing, and feedback; financial considerations; and the approach format. Table 4 (see below) summarizes specific improvement practices.
Receiving the full protocol versus a synopsis at the time of the feasibility assessment was the top recommendation, with more than 70% of sites reporting this as a top choice. Sites advocate for standard information being captured to avoid redundancy and ensure the assessment is focused on study-specific versus generic information. Sites also suggest a draft budget as well as compensation for the time and effort to complete feasibility assessments. One-third of sites believe this would improve the overall process.
Sites also see opportunities to adopt a different approach to the entire process, such as use of live discussions versus use of questionnaires or having a person available to address questions. While these rank lower in priority, they, nonetheless, present food for thought in terms of how the industry can improve the qualification process.
In a separate Tufts CSDD study, sponsors and CROs report that they are already taking steps to address these site suggestions. They report, for example, that they are providing the final protocol versus only a synopsis for almost half (42.7%) of the study opportunities that they are now evaluating.
Concluding thoughts
Feasibility, qualification, and site selection are foundational activities that ultimately impact clinical trial quality and performance. This study is the first to benchmark feasibility and qualification processes. Insights from this study help identify opportunities to improve these processes and optimize sponsor, CRO, and site collaborations. Future research will look to gather feedback from an even larger sample of investigative sites and to monitor trends identified in this original study.
Beth Harper, MBA, is Project Manager, Senior Research Consultant; Zachary Smith is Assistant Director, Data Sciences and Analytics; Ruby Madison Ford is Research Analyst; and Ken Getz, MBA, is Executive Director and Professor; all with Tufts Center for the Study of Drug Development (Tufts CSDD)
Acknowledgements: We would like to express our gratitude and acknowledge the companies that participated and provided funding for this working group study—AstraZeneca, Amgen, Biogen, Bristol Myers Squibb, Daiichi Sankyo, Gilead, GSK, ICON, IQVIA, Merck, Parexel, PPD, Roche, Sanofi, and Worldwide Clinical Trials. We would also like to extend our appreciation to the Diligent Qualification Platform for its collaboration and to the many investigative sites who completed the survey.
References
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4. Fixing Feasibility: Collaborative Approaches for Redefining and Improving Site Selection. Association of Clinical Research Professionals blog post. March 21, 2024. https://acrpnet.org/2024/03/21/fixing-feasibility-collaborative-approaches-for-redefining-and-improving-site-selection
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