CRO Site Optimization: What Works for Equity-Focused Trials

Despite decades of clinical research advancement, Black patients only make up 5% of clinical trial participants. For clinical research organizations (CROs), this disparity isn’t just an ethical concern, but a challenge that impacts enrollment times, regulatory approval, and, most importantly, the delivery of life-saving treatments to the communities that need them the most. To help address this, CRO site optimization must evolve beyond traditional metrics to embrace equity in trials, which will ultimately result in both improved clinical outcomes and business performance. 

The Limits of Traditional Site Selection

CROs tend to select sites based on existing infrastructure, geographic convenience, patient volume, principal investigator experience, and past enrollment performance. While these factors once aligned with a research model centered on efficiency and speed, this approach has led to a significant unintended consequence: a systematic exclusion of communities of color from clinical research opportunities. 

Yet the barriers to participation aren’t only logistical—they’re deeply rooted in historical and cultural realities. Generations of medical abuses and unethical research practices have fostered justified skepticism of the health system among many marginalized populations. This mistrust, combined with traditional site selection that prioritizes academic medical centers and investigators in more affluent, predominantly white communities, reinforces patterns of exclusion and limits fair representation in trial participation.

The business impacts of this equity gap extend far beyond compliance concerns. Studies that fail to meet diversity targets face regulatory delays, protocol amendments, and extended enrollment periods. And therapies developed without adequate representation may be less effective—and less safe—for the populations most in need.

This exclusion also slows down trials. Between 2017 and 2023, site activation cycle times increased by two months due to site oversaturation and the increased complexity of studies. This begs the question: If the traditional approach to CRO site optimization is becoming less effective, isn’t it time to reimagine your strategy? 

Inclusive Site Selection Strategies for CROs

It’s essential that we expand the definition of what we consider a “high-performing” site— moving beyond traditional metrics like speed and enrollment volume to include reach, representation, and trust within underserved communities. Acclinate combines cutting-edge technology with community engagement to connect, educate, and empower these populations, showing that equity-focused approaches can actually enhance trial performance outcomes. Vital approaches to improving site selection for clinical research include:

Expanding Key Criteria 

Inclusive site selection begins with community-centered metrics. Rather than solely focusing on past enrollment numbers, we need to evaluate a site’s cultural competency, language capability, and existing relationships with underrepresented communities. This means determining if sites have culturally appropriate patient materials, multilingual staff, and established trust within the communities they serve. Sites that are easily accessible to communities of color, connected to community health centers, and that have existing relationships with faith-based organizations often outperform academic centers when it comes to diverse enrollment. 

Prioritizing Inclusive Infrastructure 

Equity-focused CRO site optimization requires flexible infrastructure that meets communities where they’re at. You must prioritize accessible technology, including telehealth options, flexible scheduling, mobile research units, and digital platforms that don’t require high-speed internet or the newest devices. Transportation and childcare support are more than just nice-to-haves as well—they are integral to site structure. And sites that feel welcoming and familiar, like those that have wide staff representation, appropriate signage, and relevant health resources, create the foundation for trust that many sites lack.

Training Staff and Engaging the Community 

Most importantly, equity-focused site selection needs to include the cultural competency of staff and community engagement. A successful site has staff that have received bias recognition training, understand the context of medical mistrust, and have established relationships with community leaders and advocacy organizations. 

5 Ways CROs Are Improving Trial Site Performance by Advancing Equity 

 Equity-focused CRO site optimization improves representation metrics and enhances overall trial performance. And when community engagement is at the forefront of site selection, sites often excel in areas that traditional metrics can overlook. Top CROs place importance on: 

1. Pre-study community outreach: Effective equity-focused site optimization begins way before the first patient enrolls. Demographic mapping and communication assessment can help CROs identify not just where potential participants live, but how to engage them. This can help to build awareness and trust, creating a pool of potential participants who are already informed and interested in research participation. With Acclinate’s NOWINCLUDED community platform, CROs can begin relationship-building in the study’s area before site activation begins.
2. Enhanced site networks through community partnerships: Looking beyond academic medical centers for trial sites opens the doors to federally qualified health centers (FQHCs), community clinics, and specialty practices that serve diverse populations. These sites often have strong patient relationships and loyalty, which can translate to faster enrollment and higher retention rates. Acclinate’s existing relationships with community health centers, faith-based organizations, and cultural institutions can help CROs expand their site networks and reduce site activation timelines while improving diversity metrics. In a partnership with Cencora Good Neighbor Pharmacies, Acclinate leveraged trusted pharmacies within communities of color to create new pathways for clinical research engagement. The ensuing interaction felt both natural and accessible to potential participants, showing how improving trial site performance can often require thinking outside the box to better engage communities.
3. Hybrid and tech-fueled recruitment models: CROs can remove access barriers and expand site networks by taking advantage of tech-enabled and hybrid site models. Acclinate’s proven hybrid approach combines traditional site recruitment with community-based engagement. This typically increases enrollment rates while meeting diversity targets faster than traditional methods alone. NOWINCLUDED acts as a digital bridge, helping community members access trusted health sources, share their unique health stories, and connect with other members with lived experiences. This approach creates the foundation of trust necessary for successful clinical research participation.
4. Monitoring and optimizing outreach efforts in real time: Technological advancements in AI can further enhance our ability to identify and engage populations for clinical trials effectively. NOWINCLUDED and e-DICT, Acclinate’s predictive analytics platform, demonstrate how technology can scale community engagement and create sustainable competitive advantages for CROs. e-DICT allows CROs to monitor community engagement, like that driven by NOWINCLUDED, and predict enrollment success before launching recruitment campaigns, providing unparalleled visibility into community engagement by tracking trust, content engagement, and readiness to participate.
5. Multi-study community relationship building: By focusing on ongoing partnerships, CROs can create sustainable relationships that benefit multiple studies over time. Instead of going into a community and conducting one clinical study, it’s important to continuously cultivate these relationships. CROs report faster enrollment in subsequent studies when leveraging established community connections. 

Where Technology Meets Trust: Partnering With Acclinate 

Traditional trial recruitment uses cognitive trust to help potential participants feel confident in joining a trial. But communities of color may be rightfully skeptical. This is why affective trust is so important.

NOWINCLUDED addresses medical mistrust by creating spaces for education, connection, and empowerment before recruitment begins. The platform primes community members with information on conditions and health resources, while providing a place to connect with one another. And with over 100,000 community members, it's a trusted source of health information specifically designed by and for communities of color.

A prime example of this community-oriented approach in action is Acclinate’s work with Lightship on an Alzheimer’s clinical trial. Using NOWINCLUDED, Lightship built trust and educated community members before recruitment even began. The partnership resulted in increased African American participation in an area where such representation was historically low, illuminating how inclusive site selection strategies can create measurable improvement in both equity and enrollment.

In the coming years, regulatory pressure for inclusive trials is likely only going to increase. The FDA’s growing emphasis on demographic diversity, even amid pushback from the current administration, signifies a shift toward research that truly serves all populations. So now, the question isn’t whether CROs can afford to invest in equity-focused site optimization, it’s whether they can afford not to.

Ready to see how Acclinate can enhance your CRO’s equity strategy? Schedule a 1:1 meeting with our team.