Site Feasibility in Clinical Trials: 2026 Best Practices

Choosing the right locations for a clinical trial is one of the most critical decisions a sponsor can make. Get it right, and the study has a strong foundation for success. Get it wrong, and you risk delays, budget overruns, and even complete trial failure. With nearly 80% of trials failing to meet their enrollment timelines, the stakes couldn’t be higher. This is where a thorough site feasibility assessment becomes your most valuable tool. In short, site feasibility is the systematic process of evaluating whether a potential research site has the right resources, patient population, and experience to conduct a specific clinical trial.

This guide breaks down everything you need to know about the site feasibility process, from the initial questions to the final selection.

What Is Site Feasibility and Why Does It Matter?

At its core, site feasibility is the systematic process of evaluating whether a potential research site is truly equipped to conduct a specific clinical trial. It’s a sponsor’s due diligence, as required by guidelines like ICH Good Clinical Practice, to verify a site has the right resources, patient population, and experience to succeed.

Think of it as an upfront investment in the trial’s health. Weaknesses discovered during the site feasibility phase can prevent a cascade of problems later, including protocol deviations and missed milestones.

The Scope of Site Feasibility

The scope of a proper assessment is broad, covering every factor that influences a site’s ability to perform. This includes:

Past Experience: The site’s track record with similar trials.
Patient Access: Availability of eligible patients.
Staff Qualifications: The expertise of the investigator and research staff.
Infrastructure: The right labs, equipment, and storage facilities.
Regulatory Standing: A clean compliance history and efficient ethics committee timelines.

Each element is a piece of the puzzle, and their importance can shift depending on the study’s specific needs.

The Key Phases of Site Feasibility Assessment

A comprehensive site feasibility process can be broken down into four main assessment phases, each looking at the site from a different angle.

1. The Profile Phase

This initial phase is about gathering the basics. Sponsors collect fundamental information about the site and its key personnel, usually through a Site Feasibility Questionnaire (SFQ). This profile includes the investigator’s qualifications, the site’s location, and a general description of the facility. The challenge here is that sites often face redundant questions, like “Do you have a freezer on site?”, from sponsors they have worked with before.

2. The Capability Phase

Next, the focus shifts to whether the site has the necessary resources and infrastructure. Can the site actually do the work? This evaluation looks at tangible assets like laboratory facilities, emergency care capabilities, and protocol specific equipment. It also assesses technology readiness, including experience with electronic data capture (EDC) systems or remote monitoring tools. Any gap, like a missing MRI machine for a study that requires it, could be a dealbreaker.

3. The Performance Phase

Here, past behavior is the best predictor of future results. The performance phase evaluates a site’s track record. Did they meet enrollment targets in previous trials? What is their participant retention rate? This is crucial because industry data paints a stark picture: approximately 48% of sites under enroll, and a shocking 11% fail to enroll a single patient. By scrutinizing a site’s history, sponsors can avoid partnering with sites that consistently underperform.

4. The Protocol Specific Assessment

This is where the assessment gets tailored to the study at hand. The questions become highly specific: based on this protocol’s inclusion and exclusion criteria, how many eligible patients can you realistically enroll? Can you perform all the required procedures on schedule? Sites are asked to forecast recruitment rates and timelines for this particular study. This stage requires clear communication, as sites sometimes lack enough detail about the protocol to provide accurate estimates.

Perspectives in the Feasibility Process

Successful site feasibility requires a clear understanding of what both sponsors and sites need to achieve.

What Do Sponsors Prioritize?

Sponsors ultimately want two things: timely enrollment and high quality data. Their top priorities in site selection are therefore patient availability and a proven track record. They look for sites with access to a large pool of eligible patients and a history of delivering on their promises. The cost of a poor choice is enormous. Delays can cost an estimated $37,000 per day in operational expenses, and many sponsors find their original timelines double just to meet enrollment goals.

The Importance of Site Self Assessment

Before a site even responds to a sponsor, it should conduct its own internal evaluation. This site self assessment is a critical reality check. The research team must honestly ask, “Can we successfully execute this study with our current workload and patient population?” When this step is skipped, the consequences are severe. Almost one third of all activated research sites end up enrolling zero patients. Furthermore, an estimated 55% of trials are terminated early simply because they cannot recruit enough participants.

Key Tools and Common Challenges

The site feasibility process relies on specific tools and methodologies, but it isn’t without its hurdles.

The Site Feasibility Questionnaire (SFQ)

The SFQ is the backbone of the process. This structured survey collects data on everything from investigator experience and facility infrastructure to patient demographics and recruitment projections. While essential, these questionnaires are a significant burden for sites. The average clinical research coordinator spends around 264 hours per year just filling out feasibility forms.

Data Collection and Analysis

Information is gathered through SFQs, interviews, and feasibility platforms. Once collected, this data must be analyzed to identify the best sites. However, many organizations struggle to turn this data into action. While 74% of organizations aim to be data driven, only 29% are successful at connecting analytics to decisions. This highlights a common gap between collecting feasibility data and using it effectively.

The Patient Eligibility Challenge

Finding enough patients who meet a protocol’s strict criteria is a massive challenge. Effective patient recruitment strategies are essential. In oncology, for example, only 2% to 3% of adult cancer patients participate in trials, partly due to restrictive eligibility. This bottleneck has a direct impact on trial success and contributes to the high rate of studies terminated for low accrual.

The Staffing Challenge

A site is only as good as its people. The staffing challenge involves ensuring a site has enough qualified and available staff to run a trial. High turnover and burnout are rampant in the industry, with CRA turnover around 30%. A feasibility assessment must confirm that the principal investigator can dedicate sufficient time and that experienced coordinators are available to manage the trial’s daily demands.

Understanding the Costs of Feasibility

Financial planning is deeply intertwined with the site feasibility process, as early decisions have major downstream budget implications.

Feasibility and Budgeting: The feasibility process itself is an investment to prevent much larger costs later. A key consideration is managing risk. Opening more sites increases upfront costs, but opening too few risks missing enrollment targets, which leads to expensive delays.
Start Up Cost: Every site that gets activated incurs start up costs for contract negotiations, ethics committee submissions, and staff training. This expense typically ranges from $20,000 to $30,000 per site. If a site fails to enroll, that money is lost. For practical ways to shorten activation timelines, see our study start-up guide.
Medical Procedure Cost: Modern trials are complex. The median number of procedures in a trial protocol jumped by about 50% in a single decade. These costs, for everything from MRIs to lab tests, are a major part of the trial budget and must be carefully planned.
Adverse Event Reporting Cost: Documenting and managing adverse events requires significant staff time and resources. Leveraging modern reporting tools can streamline SAE capture and oversight during feasibility planning and execution.
Participant Travel Cost: Travel and time commitments are a major barrier for patients. To overcome this, sponsors often reimburse travel costs. A survey found that 66% of people would be more willing to join a trial if it used technology to reduce the number of site visits, such as patient engagement solutions.

Best Practices for a Modern Feasibility Strategy

To overcome these challenges, sponsors and CROs are adopting more strategic and efficient approaches to site feasibility. Explore clinical trial operations best practices that complement a modern feasibility strategy.

Embracing Remote Site Evaluation

Instead of costly in person visits, many assessments now happen remotely using digital tools like decentralized clinical trials technology. This can involve video interviews, virtual facility tours, and electronic document reviews. Technology allows sponsors to evaluate more sites efficiently, including smaller or community based sites they might have otherwise overlooked. Platforms like the one offered by Curebase are built to facilitate this kind of modern, remote interaction between sponsors and sites.

Prioritizing Clear Communication

Communication breakdowns are a common source of friction. Sites report frustration when the people contacting them for feasibility cannot answer basic questions about the protocol. One site coordinator noted that callers sometimes “can’t even pronounce the name of the drug.” Strong, transparent, two way communication is essential for building trust and ensuring the feasibility data collected is accurate.

The Phased Approach and Early Initiation

Instead of a one size fits all assessment, a phased site feasibility approach is more efficient. This involves an initial broad screening to gauge basic interest, followed by a more in depth assessment for a smaller pool of promising sites.

Furthermore, it’s best to start the site feasibility process as early as possible, even while the protocol is still being finalized. This front loads the work and can dramatically shorten the time from protocol approval to enrolling the first patient. However, it’s crucial to avoid premature site engagement, where a CRO contacts sites before the protocol or budget is stable, which can lead to confusion and wasted effort.

Distinguishing Protocol vs. Site Feasibility

It’s important to separate two distinct evaluations:

Protocol Feasibility: Asks, “Is this study design achievable in the real world?” This is a macro level look at the protocol itself.
Site Feasibility: Asks, “Can this specific site successfully execute this protocol?” This is the micro level assessment of an individual site’s capabilities.

A trial can fail if either one of these is flawed. The protocol must be sound before you can find the right sites to run it.

How to Create a Streamlined Feasibility Process

A streamlined feasibility process is about working smarter, not harder. It aims to reduce redundant steps, speed up decisions, and ease the burden on sites. This is achieved through standardization, technology, and clear collaboration.

Using a site feasibility best practice checklist ensures every potential partner is evaluated against the same critical criteria, from patient access and staff experience to infrastructure and performance history.

For sponsors working with CROs, a guide for site feasibility is essential. It should clearly define roles, establish communication protocols, and align both parties on the criteria for a successful site. This ensures that even when the work is delegated, the sponsor’s priorities remain the focus.

Ultimately, the goal is to leverage technology to move beyond endless spreadsheets and repetitive questionnaires. A unified platform that connects sponsors, CROs, and sites on a single system can transform the process. The platform from Curebase is built to do exactly this, allowing feasibility data to flow seamlessly. This integration leads to better data quality and accelerated timelines, helping get trials started faster with more confidence in site selection.

Frequently Asked Questions

1. What is the main goal of site feasibility?
The primary goal of site feasibility is to select the most qualified and capable research sites that can successfully enroll the required number of patients on time and produce high quality, compliant data for a clinical trial.

2. Who is responsible for conducting site feasibility?
The trial sponsor holds the ultimate responsibility for ensuring a proper site feasibility assessment is done. However, they often delegate the execution of these activities to a Contract Research Organization (CRO).

3. How does technology improve the site feasibility process?
Technology streamlines the process by using centralized platforms for data collection, enabling remote site evaluations, supporting eConsent, and providing analytics to support data driven decision making. This reduces the administrative burden on sites and accelerates the selection timeline for sponsors. Explore how the Curebase platform modernizes this process.

4. Why do so many clinical trial sites fail to enroll patients?
Sites fail to enroll for many reasons identified during feasibility, including an insufficient pool of patients who meet the protocol’s strict eligibility criteria, competition from other trials, and inadequate staffing or resources to dedicate to recruitment.

5. What is the difference between protocol feasibility and site feasibility?
Protocol feasibility assesses if the trial design itself is viable on a broad scale (e.g., can enough patients be found globally?). Site feasibility is a more granular assessment of whether a specific site has the resources, experience, and patient population to execute that protocol successfully.

6. How can sponsors and sites collaborate better during feasibility?
Better collaboration starts with clear, timely, and transparent communication. Sponsors should provide all necessary protocol information, and sites should be honest about their capabilities and limitations. Using a shared technology platform can also greatly improve collaboration. See how Curebase connects sponsors and sites.

7. What is a Site Feasibility Questionnaire (SFQ)?
An SFQ is a survey sent by sponsors or CROs to potential research sites to gather essential data. It covers topics like the investigator’s experience, patient population statistics, facility equipment, and past trial performance to help determine if the site is a good fit for a study.