Mona Shahriari, MD, FAAD’s Stepwise Framework for Building a Clinical Research Unit

Today at Winter Clinical Miami 2026, Mona Shahriari, MD, FAAD, associate clinical professor of dermatology at Yale University and associate director of clinical trials at CCD Research, outlined a stepwise framework for building and scaling a successful clinical research unit.¹ Drawing from her own evolution—from a single coordinator and one exam room 6 years ago to a robust clinical trials division enrolling patients and publishing data—Shahriari emphasized that thoughtful infrastructure and strategic planning, not size alone, determine success.

The Power of Precision

Her first principle was clear: know your numbers. Before hiring staff or engaging with sponsors, practices must understand their patient volume and disease distribution, particularly in commonly studied conditions such as psoriasis, hidradenitis suppurativa, and alopecia areata.

“Sponsors love numbers,” Shahriari advised attendees. “So the more specific you are, the more credibility you come off to those individuals.”

Rather than estimating, investigators should be prepared to report precise monthly volumes, such as the number of psoriasis patients seen and the proportion with moderate-to-severe disease. Running internal EMR reports allows practices to determine feasibility and present credible projections that align with enrollment expectations.

Quality Over Quantity

Second, Shahriari encouraged attendees to “start lean and scale intentionally” and prioritize “commitment, consistency, and connection” over size. A viable research unit does not require a large, standalone facility. At minimum, 1 principal investigator, 1 clinical trials coordinator, lab access, and a dedicated exam room can support high-quality research. Sponsors value responsiveness, protocol adherence, low screen-failure rates, and strong patient retention more than sheer size. Smaller sites may even offer advantages, including staffing continuity and enhanced patient engagement, both of which strengthen sponsor relationships and long-term growth opportunities.

Mastering the Feasibility Questionnaire

A key operational focus of the session was mastering the feasibility questionnaire, which Shahriari described as a sponsor’s risk assessment tool. These questionnaires evaluate patient access, infrastructure, investigator experience, and operational timelines such as IRB turnaround. She advised practices to maintain updated site capability documents, including monthly patient metrics, staff credentials, and prior research experience, to streamline responses. Importantly, no question should be left blank; omissions may be interpreted as a lack of capability. Sites should also highlight differentiators such as evening or weekend visits, diverse patient populations, pediatric access, or prior publications in the therapeutic area.

Integrating Research into Daily Clinic Flow

When selecting initial trials, Shahriari cautioned against pursuing only high-profile phase 2 or 3 studies. Instead, she recommended beginning with registry or phase 4 studies to refine workflows, documentation processes, and sponsor communication. Early studies serve as operational “dry runs,” allowing teams to optimize scheduling, patient screening, and data handling before scaling to more complex protocols.

Integration into daily clinic flow was another critical theme. Shahriari described distinct workflows for enrollment versus follow-up visits, including EMR flagging systems for pre-screened patients and use of investigator scripts to standardize trial discussions. Practices may choose dedicated research days or integrate research visits throughout clinic sessions; flexibility should align with patient needs and operational capacity. She also stressed rapid scheduling for eligible patients to avoid missed enrollment windows and cautioned against competing trials with overlapping inclusion criteria.

Operational logistics extend beyond workflow. Shahriari outlined foundational requirements: a separate research financial structure, confirmation of malpractice coverage for trial activities, essential equipment (e.g., locked investigational product storage, temperature-monitored refrigeration with backup power, centrifuge), and dedicated communication systems. Even modest infrastructure, if organized and compliant, can support high-level research activity.

Building a Self-Sustaining Reputation

Finally, Shahriari encouraged dermatologists to actively network with medical science liaisons and industry contacts to build visibility. For new investigators, initial self-advocacy is often necessary. However, once reliability and performance are demonstrated, sponsor relationships tend to become self-sustaining.

“Everybody wants that flashy, fancy phase 2 [or] phase 3 trial with novel methods of action. But the reality is registry studies page, phase 4 studies as well...those lower complexity protocols are a better place for you to start,” she concluded. “When you're first starting out, the first couple of trials are for you to build your reputation as well as strengthen and build that clinical trial center and optimize the workflows.”

Reference

1. Shahriari M. How to Incorporate Clinical Trials Into a Practice. Presented at: 2026 Winter Clinical Miami Dermatology Conference; February 27-March 1, 2026; Aventura, FL