What CROs Cite as Their Top Clinical Trial Challenges and How They Plan to Overcome Them in 2025

In a rapidly evolving clinical research landscape, there is a greater need now more than ever for pharma and biotech companies to outsource trial management activities to contract research organizations (CROs), which are taking on an increasingly strategic role.

CROs have become much more prominent as key partners throughout every stage of drug discovery, supporting patient recruitment, trial execution, regulatory compliance and more to ensure efficacy, efficiency and safety. In fact, according to a recent report, “the global contract research organization market size was valued at USD 52.19 billion in 2023 and is anticipated to reach around USD 104.60 billion by 2033, growing at a CAGR of 7.2% from 2024 to 2033.”

Findings from Greenphire’s recent survey highlight the views of industry professionals on top challenges, optimal participant and site experiences, the role of technology and strategies for enhancing diversity in clinical research.

In this article, we will dive into the perceptions, specifically of CROs, on these key topics.

Top Challenges as Identified by CROs

Repeatedly, we see the same hurdles impacting clinical research. Let’s look at how CROs view these challenges and how that compares to the outlook of sponsors:

• Diverse patient enrollment: 73% of CROs find enrolling diverse patient populations challenging, reflecting a growing need for solutions that can support outreach and inclusion efforts
• Navigating global regulations: 64% struggle with variations in regulatory requirements per region, illustrating the complexity of managing compliance across multiple countries
• Recruitment and retention: Nearly half (46%) of CROs find recruiting and retaining the desired number of participants throughout the trial to be difficult, underlining the need for efficient and engaging trial designs

As compared to CROs, sponsors found the top three challenges to be recruitment and retention (72%), followed by protocol complexity (68%) and navigating global regulations (54%). Interestingly, where CROs identified enrolling diverse patient populations as their top challenge, sponsors had this toward the bottom of their list, only above keeping up with technology & innovations (42%).

Prioritizing the Participant Experience

In recent years, there has been an increased focus on ensuring a positive participant experience in clinical trials. CROs recognize that participant satisfaction is key to trial success and there are more ways than ever to help optimize their experience. Here are some of the features that CROs consider most important:

• Flexible payment and reimbursement: 82% of CROs value offering a choice of payment methods and real-time reimbursement capabilities, empowering participants with seamless financial support
• Data-triggered patient payments: 73% of CROs see value in solutions that automate payments based on participant activities (e.g., ePRO diary completion), which reduces administrative burdens and while driving protocol compliance and participant satisfaction
• Concierge support: 73% of CROs say that patient concierge services, covering all logistical arrangements and costs, are crucial for keeping participants engaged and compliant throughout the study

Focus on Site Experience

The site experience is equally critical, with CROs acknowledging that site empowerment often leads to a more successful clinical trial. This includes ensuring financial sustainability and streamlining traditionally tedious processes:

• Consistent site payments: 100% of CROs agree that timely, predictable payments are crucial for a positive site experience; plain and simple, if sites aren’t paid on time, they can’t maintain their operations
• Streamlined study startup: 100% of CROs prioritize accelerating budget negotiation and site startup processes as it is this stage in a clinical trial that often causes delays
• Reducing site burdens: 82% of CROs feel that relieving sites of logistical and administrative tasks (such as patient travel coordination or payment execution) is important, giving them time to focus on patient care and protocol-related activities

Breaking Down Barriers to Diversity

With diversity being paramount for sponsors, diverse recruitment proves to be a key priority for CROs as well. As such, 100% of survey respondents agreed that eliminating financial and logistical barriers is a core part of their diversity action plans. Removing these major barriers to participation not only improves accessibility but also helps CROs build more inclusive trials that better represent real-world patient populations.

Top 3 Technology Considerations for CROs

In this day in age, technology plays a pivotal role in clinical trials. The key is identifying solutions that are the right fit for your specific trial needs. When it comes to choosing new technology solutions, CROs identified the following as their top areas of importance:

• User-friendly interface
• Flexible delivery models
• Cost-effectiveness/ROI

A common theme throughout the survey responses, including this question, is the focus placed on ease of use and flexibility of technology, indicating the importance of ensuring a positive experience for end users — whether participants or sites.

Addressing Pain Points

If given the chance to solve one problem, CROs emphasized the following as their top responses:

• Startup efficiency: Streamlined setup and materials preparation are essential
• Patient recruitment: Despite the existence of eligible participants, matching them with appropriate trials remains a challenge
• Regulatory complexities: Complicated regulatory requirements continue to slow down clinical trial processes, especially as they relate to patient payments

Final Thoughts

The central reason for conducting surveys like this is to hear from the people who live and breathe clinical research and truly have their fingers on the pulse of the top challenges, priorities and opportunities for improvement.

CROs are just that — key stakeholders on the frontlines of clinical research, with the core goal of conducting trials in the most efficient, compliant and effective manner. This makes their feedback, along with sponsors and sites, immensely valuable in understanding where change is needed and how we can drive innovation in clinical research.

Topics: Contract Research