Clinical Research Site Challenges: What Sponsors and CROs Need to Know

Clinical research sites carry much of the weight of executing a study, but the decisions that shape their workload, from protocol design to contract terms, are made well before a site ever opens for enrollment. WCG’s 2026 Clinical Research Site Challenges Report, “The Cost of Complexity,” gathered feedback from more than 400 clinical research professionals to identify exactly where that weight is building and why. 

For sponsors and CROs, this report offers more than a snapshot of site challenges. It provides a roadmap. When sponsors and CROs understand what sites are experiencing, they can intervene earlier, before a budget dispute stalls a contract or a protocol amendment adds months to a timeline. The result is faster study start-up, meaningful savings, and therapies that reach patients in need sooner. 

What Are the Top Challenges Facing Clinical Research Sites in 2026?

Sites have pointed to the same top challenges time and time again, and this year, all of them grew.  

Trial complexity climbed six points this year. Forty-one percent of sites now cite it as their leading challenge, up from 35 percent in 2025.  

Site staffing issues rose to 39 percent, up from 30 percent.  

Contract and budget delays reached 37 percent, up from 31 percent.  

Challenges this persistent rarely begin at the site. They take shape earlier, in feasibility, protocol design, benchmarking, and the way sponsors, CROs, and sites work together day to day. That is where the opportunity to provide relief is greatest. 

What Is Causing Trial Complexity to Increase? 

Protocol complexity sits at the root of the strain. Sixty-six percent of sites now rate protocol complexity as moderately high or very high, a notable jump from the prior year.  

Data from Tufts Center for the Study of Drug Development shows that ten years ago, a protocol may have asked a site to perform 200 procedures, but today that number would be more than 300. Additionally, Tufts found that the average Phase III protocol now generates close to six million datapoints, and that number continues to grow year-over-year. Denser protocols mean more procedures, more data collection points, and more administrative work layered onto already stretched staff. 

This year, 40 percent of sites reported taking on moderately more trials, yet only 26 percent increased staffing to match that added volume. That gap between study complexity and available personnel is where burnout lives. Smaller, independent sites feel this most acutely, with 47 percent naming trial complexity as their top issue. 

How Staffing Affects Site Performance and Study Start-Up 

The effects of staffing shortages cascade through every stage of a trial, from initial feasibility to ongoing patient visits. Existing staff absorb the extra workload when sites cannot hire fast enough, which increases the risk of errors, delays in data entry, and burnout among experienced coordinators and investigators. Larger sites, including academic medical centers and site networks, report staffing as their most acute pressure, with 44 percent ranking it as a top challenge. 

Staffing shortages create consequences beyond operational slowdowns. Under-resourced teams must navigate the documentation, training, and coordination required for study start-up – before enrollment even begins. This pressure also affects the participant experience by taking time away from the direct engagement essential to retention and study success. 

The Role of Contracts and Budgets in Study Delays 

Budget negotiation stands out in the report as the single largest source of start-up delay. Sites report that financial strain often comes from underfunded budgets and administrative work that is never reimbursed. Combined with the time spent negotiating contract terms, these financial friction points routinely stretch the already-long study start-up window. 

Sites reported that study start-up most commonly takes two to four months to complete, and 46 percent of sites said that faster contracting and budgeting would have the greatest impact on improving their site’s performance. Contract and budget issues delay trial initiation while also creating downstream pressure that affects staffing decisions, site morale, and a sponsor’s ability to meet enrollment targets. 

What Can Sponsors and CROs Do to Address These Site Challenges? 

The challenges sites report rarely originate at the site level. They take shape earlier, during protocol design and budget development, long before a site signs a contract. This is precisely why sponsors and CROs are positioned to make the biggest difference. 

Approximately 87 percent of clinical research professionals report delays in trial timelines due to protocol amendments. When sponsors build protocols around realistic site capacity and patient populations from the outset, they reduce the need for costly mid-study revisions. Fifty-five percent of sites spend 20 percent or more of their start-up time on amendments alone, which represents weeks of unrecoverable efforts per study. 

Incorporating feasibility testing early in the design process can reduce avoidable amendments that cost sponsors and CROs time and money and add burden to already overloaded site staff. Implementing standardized, benchmarked budget templates to streamline contract negotiation and using AI-enabled congruency tools to highlight misalignments early can reduce time spent on a process that unnecessarily adds to study start-up. 

The benefits of acting on this feedback extend well beyond the site. Sponsors and CROs that address complexity upstream see faster study start-up, meaningful reductions in unplanned spending, and a shorter path to bringing new therapies to the patients who need them. Faster, cleaner trials also reduce the administrative burden that contributes to site burnout, helping preserve the long-term site relationships sponsors depend on for future studies. 

Stop Paying Downstream for Complexity You Can Resolve Upfront 

Sites have clearly named the problems. Trial complexity, staffing strain, and contract and budget delays are not new challenges, but they are growing ones, and the cost of inaction compounds with every study. Sponsors and CROs that act on this feedback will see faster start-up, lower costs, and therapies that reach patients sooner.

Turn Site Insights Into Action

Download WCG’s 2026 Clinical Research Site Challenges Report for the full findings, year-over-year insights, and practical recommendations to address complexity before it becomes rework, added cost, or delay. 

Complete the form to download the report.