Monroe Biomedical Research builds new facility to support early-phase trials

By Nancy Lamontagne | This article originally appeared on NCBiotech's blog
Monroe Biomedical Research (MBR), a dedicated clinical trial site, is growing its footprint to enhance early-phase clinical trials and attract more research opportunities to North Carolina.
Construction is underway on a new 12,000-square-feet facility adjacent to MBR’s existing 7,000-square-feet space in Monroe. Set for completion in June 2025, the new facility will include 15 beds and accommodations for study volunteers requiring extended stays. MBR’s two buildings will be registered as a dedicated private research campus, enhancing the state’s capacity for early-phase clinical trials and attracting more studies to the region.
The expansion builds on a decade of success for MBR. “As a dedicated clinical trial site, our team includes dedicated departments for regulatory oversight, quality assurance, protocol adherence and patient recruitment,” said Benjamin B. Karsai, chief business development officer at MBR.
Our site infrastructure is designed to support a high volume of study volunteers while maintaining the highest standards of data integrity. We are one of the top-enrolling research centers in the state, with extensive experience conducting obesity, diabetes, cholesterol, hypertension, addiction, and vaccine studies. We’ve passed three FDA audits with a perfect record, reinforcing our commitment to excellence in clinical research.”
Expansion plans
Although MBR has conducted early phase studies at its current facility, only a limited number of patients could be seen due to space constraints. The new facility will be two stories, with the entire top floor dedicated to inpatient beds.
MBR’s current and new facilities, which share a parking lot, will create 19,000 square feet of dedicated industry-sponsored clinical trial space. Registering them as a single private research campus will help ensure a streamlined and compliant clinical trial environment.
“Through long-term collaborations with major sponsors and biotech companies, we have established ourselves as a trusted site for large-scale trials and master protocol studies, helping bring more clinical trials to NC,” said Karsai.
“This expansion will further accelerate our growth, positioning our site to partner with sponsors, CROs and biotech companies on phase I and complex early phase trials.”
Engaging a broad patient base
MBR’s location in Monroe, roughly 20 miles southeast of Charlotte, provides a valuable advantage. Sponsors often look for geographic diversity in site selection, and MBR gives them an NC option outside of the Research Triangle region.
MBR has also built a strong track record in enrolling diverse patient populations, which is essential for developing medications that work effectively across different groups of people. Karsai said this evolved naturally thanks to the company’s patient-centric approach, a focus on hiring passionate study team members and consistently delivering high-quality work within the community over the past decade.
“Serving as a testing site during the COVID-19 pandemic helped accelerate our outreach,” Karsai said. “Today, we are recognized as a leading site for recruiting diverse populations, helping sponsors achieve their inclusion goals to develop safe and effective treatments for people of all backgrounds.”
Looking ahead
In addition to expanding the infrastructure in Monroe, the company has plans to open other locations, including one in North Charleston, SC. This expansion aligns with its broader strategy to build a network of high-quality, specialized research centers, each focusing on critical therapeutic areas of clinical trials.
“We welcome the opportunity to work with physicians who are both excited by clinical research and understand its importance to medicine,” explained Suvi Gross, CEO of MBR. “Our goal is to create a comprehensive high-quality network of sites that are capable of conducting a wide variety of trials including cardio/metabolic, endocrine, nephrology, psychiatry, GI and oncology studies.”
"We're really excited to see this kind of expansion in Monroe, and we're looking forward to seeing more and more clinical trials take place there," said Corie Curtis, executive director of the Greater Charlotte Office of the North Carolina Biotechnology Center.