First Activated Site Becomes Highest Enroller in Depression Trial

The sponsor was facing a six-month first-patient-in delay, with no sites activated nationwide and an urgent need to enroll 200 patients across 20 sites. With the study timeline at critical risk, the sponsor needed a site that could move quickly from activation to screening while still protecting data quality, eligibility standards, and participant readiness in a complex psychiatric trial.

Denali Health Atlanta mobilized quickly across regulatory, clinical operations, recruitment, and patient engagement. Our team worked diligently to become the first site activated within six weeks, then screened the first patient in the trial within seven days of greenlight.

Once activated, we deployed a three-channel recruitment strategy:

• Dr. Maria Johnson reviewed her existing patient database and spoke directly with patients who may be a strong fit
• Our team launched local intent-based marketing to reach patients actively seeking depression treatment options
• Our recruitment team conducted targeted outreach and follow-up to educate potential participants on research as a care option

Every potential participant moved through a structured pre-screening process before formal consent. Recruiters first completed a general psychiatric and medical questionnaire. Qualified candidates were then brought on site, where the CRC and rater walked them through the study, assessed commitment, and identified disqualifiers early. Only after that step did subjects return for the formal consent visit.

This process allowed the team to protect patients, reduce avoidable screen failures, and ensure that individuals advancing toward randomization were informed, eligible, and prepared to participate.

Denali Health Atlanta became the first activated site and first site to screen in the trial. The site went on to become the highest enroller in the study.