The clinical trial landscape has evolved significantly recently, particularly in the ways sponsors engage with contract research organizations (CROs). Increased site consolidation – that is, independent sites merging into networks – and sponsors increasing their involvement in site selection are reshaping the industry in important ways. Recent reports suggest that a functional service provider (FSP) outsourcing model among large sponsors is growing at more than 13% annually. Rather than fully outsourcing a wide range of clinical trial activities to CROs, more sponsors are selectively outsourcing specific services for a given function (such as medical writing or clinical monitoring). Some industry experts suggest that the industry is moving towards a hybrid approach somewhere in between full-service and FSP.

This transitional environment, combined with an utterly broken site feasibility process, could open a big opportunity for CROs to differentiate their offerings and…essentially, save the day.

A recent survey of nearly 600 clinical research sites conducted by Advarra illustrates how gross inefficiencies in feasibility assessments slow down study initiation. Traditionally, CROs have played an intermediary role in this process, managing feasibility assessments and site selection on behalf of sponsors. However, as sponsors bring more of these capabilities in-house, and independent clinical trial sites consolidate into broader networks, CROS have an opportunity to bridge this functional gap and improve site feasibility. CROs that invest in advanced data analytics and site intelligence will be well-positioned to bring more efficiency and new value to sponsors. 

Site Feasibility Inefficiencies Put the Brakes on Study Startup 

According to the Tufts Center for the Study of Drug Development (Tufts CSDD), the global investigative site community spent an estimated $170 million qualifying for FDA-regulated, industry-funded clinical trials in 2024, which equates to 2,500 hours dedicated annually to site qualification. 

Yet the Advarra survey illustrates how inefficiencies inherent in the process continue to cultivate frustration and drag on the progress of new studies. Many of these issues have been well-known for decades and are directly attributed to antiquated and inflexible processes – only to be made worse with increased technology burdens on sites. According to Advarra’s 2023 Site Activation Survey, an oncology study can require a site to access up to 22 different systems and, on average, sites are managing a dozen different systems for a single study not including sponsor-provided solutions.

Typically, feasibility assessments fail to account for information or experiences sites have already provided on past assessments, so sites must keep providing that information again and again as opposed to just focusing on the specific circumstances of the individual trial. Continuing to ask experienced sites for the same capability information adds redundancies atop already-burdened site personnel. And this is happening across sponsors, within sponsors, and even for the same study – six in 10 respondents indicated they had received more than one feasibility questionnaire for the same study. Nearly the same number of respondents also indicated receiving feasibility surveys from both sponsors and CROs, a careless and unnecessary duplication. 

A particularly frustrating inefficiency in the site feasibility process is the two-step approach many CROs take. Before even securing a contract, multiple CROs send out initial ‘mini’ feasibility forms to sites to prove they have a viable roster for sponsors. Once a CRO is selected, sites then receive a second, more detailed feasibility questionnaire – often repeating many of the same questions. This redundant process not only wastes valuable time but also underscores the inefficiency of existing feasibility workflows. 

Despite these known deficiencies, improvements in the process have been slow to develop. For example, less than half of the sites surveyed (46%) said feasibility surveys were more focused on study-specific questions today than they were five years ago. Yet despite the onerous—and often needless—effort being put into site feasibility analysis; many sites are left out in the cold. Approximately 40% of respondents in the survey said they get invited to participate in a study less than half the time.

Solutions to many of these challenges are often far from arduous. More than half of the survey respondents indicated that standardizing site information in a centralized database was a top recommendation for improving feasibility assessments. Taking this simple step would allow sites to focus on study-specific criteria rather than wasting time answering the same generic questions repeatedly.

Site Consolidation and Direct-to-Site Trends Offer Warning Signs

As clinical trial sites consolidate into networks, there is increasing evidence that they gain operational efficiencies as well as bargaining power. The Association of Multisite Research Corporation (AMRC), which launched in January, represents 14 site networks covering more than 400 sites and 7,000 employees, including nearly 1,000 principal investigators (PIs). According to AMRC’s leadership, “Multisite networks provide scalable, reliable solutions to systemic industry challenges. With standardized processes and centralized operations, these networks are redefining clinical trials.”

This trend presents a challenge for CROs. Sponsors will now have a greater opportunity to bypass them and contract directly with large site networks. Big pharmaceutical companies with robust internal clinical operations may no longer need CROs for site identification and, instead, leverage centralized site databases within these networks, cutting out the intermediary role CROs have traditionally played. 

On the other hand, CROs have an opportunity to hone and deliver specialized expertise and streamline site feasibility, fixing a broken process that costs clinical trial sponsors significant time and money.

Investing in Advanced Data Analytics Can Yield Dividends

CROs that adopt cutting-edge technology can offer sponsors superior site intelligence. For example, CROs that adopt centralized, AI-driven site databases can aggregate and analyze site performance metrics quickly. By leveraging AI, they can match sites to studies based on historical enrollment success, investigator experience, and operational efficiency. Machine learning can enable CROs to predict which sites are most likely to succeed in each trial, reducing the reliance on repetitive questionnaires and manual, often biased, assessments. Technology can also help automate and standardize site feasibility forms, finally taking the steps necessary to solve this long-vexing challenge. 

Exciting Future for CROs in an Evolving Environment

CROs are facing increasing pressure from both sponsors and sites. Sponsors are increasingly shifting to an FSP outsourcing model, while sites are consolidating into networks that control their own data. However, CROs that invest in site intelligence, predictive analytics, and free-flowing technology solutions can offer differentiating value and improve the site feasibility process to speed study startup. 

CROs have an exciting opportunity to leverage data-driven approaches and better identify and engage with emerging site networks, ensuring they provide sponsors with the most effective trial sites rather than relying on past knowledge and outdated selection practices.

The clinical trial landscape is evolving. The rise of site networks, the increasing trend of sponsors bringing feasibility in-house, and the demand for more efficient, data-driven site selection all signal a major shift away from traditional models. For CROs that embrace innovation, there is a real opportunity to redefine their role altogether. CROs will no longer be intermediaries but will instead become indispensable strategic partners – finally fixing a broken site feasibility process – in the next generation of clinical trials.

Christine Senn, PhD is the SVP of Site-Sponsor Innovation at Advarra, a global company offering services and technology solutions to safeguard trial participants and enable collaboration across all industry domains. She has worked in clinical research since 2005, starting at the University of Vermont College of Medicine followed by Centricity Research, where she served in various business roles across strategic growth initiatives, project planning and execution, and continuous process improvement. Senn has a PhD in psychology and master’s degrees in clinical psychology and advertising and public relations. She was the 2023 Chair of the Association of Clinical Research Professionals (ACRP), is an ACRP Fellow (FACRP), and is double certified as a Certified Clinical Research Coordinator (CCRC) and Certified Principal Investigator (CPI). Senn can be reached at christine.senn@advarra.com.