Case Study: From Site Activation to Global First Randomization in Phase III Atrial Fibrillation Trial

How Profound’s embedded cardiology model, direct EMR access, and investigator engagement enabled rapid patient identification and enrollment

A large global Phase III study targeting more than 15,000 participants with atrial fibrillation presented an interesting enrollment challenge. Despite the study’s scale, participants were required to meet narrow stroke-risk criteria, significantly reducing the pool of immediately eligible patients.

Successfully identifying qualified candidates required precise, protocol-specific pre-screening and close coordination between the research team and Principal Investigator Dr. Gregory Giesler of Southern California Heart Specialists in Pasadena, California.

That approach led to two significant achievements: First Patient Screened Globally and First Patient Randomized Globally.

The Site

Through Profound Research’s embedded model, the research team at Southern California Heart Specialists worked alongside Dr. Giesler within an established cardiology practice and patient population. This integration provided direct access to EMR data while allowing the research team to draw on Dr. Giesler’s knowledge of his patients and the study’s eligibility requirements.

Together, these capabilities positioned the site to begin identifying potential candidates before activation and move quickly once screening could begin.

The Challenge: Finding the Right Patients Within a Large Population

Atrial fibrillation is a common cardiovascular condition, but a large potential patient population does not necessarily translate into straightforward clinical trial enrollment.

For this study, patients with atrial fibrillation also needed to meet specific criteria related to their risk for stroke or systemic embolism. Those protocol requirements substantially narrowed the immediately eligible population and made identifying appropriate candidates quickly especially important.

With an accelerated timeline, success depended on the site’s ability to understand the protocol, identify potentially qualified patients, and prepare for screening as soon as the site was activated.

The Solution: Embedded Research and Proactive Patient Identification

Profound’s embedded cardiology model provided direct access to an established cardiology patient population and enabled the research team to work closely with Dr. Giesler throughout the pre-screening process.

Using direct EMR access, the team pre-screened patients against protocol-specific criteria to identify potential candidates. Dr. Giesler’s knowledge of patient histories and familiarity with the study requirements provided another important layer of insight, helping the team identify qualified candidates in advance.

This preparation meant appropriate patients could be screened immediately following site activation rather than beginning the identification process after activation.

The Outcome: First Patient Randomized Globally

The combination of targeted EMR-driven recruitment, an established patient population, and close collaboration between Dr. Giesler and the Southern California Heart Specialists research team enabled the site to move quickly from activation to screening and randomization.

Key Milestones:

• Site Activation: August 7
• First Patient Screened Globally: August 10
• First Patient Randomized Globally: August 18

Southern California Heart Specialists screened the first patient globally within one business day of site activation and subsequently achieved First Patient Randomized Globally for the study.

What This Means for Sponsors

Large global trials require sites capable of identifying not simply more patients, but the right patients.

This case demonstrates the value of combining protocol-specific EMR pre-screening with the clinical knowledge of investigators who already understand their patient populations. By identifying potential candidates before activation, Profound’s embedded model can help reduce the time between site readiness and meaningful enrollment activity.

For sponsors, that means research sites positioned to begin executing as soon as they are activated—even when protocol criteria substantially narrow the eligible patient population.

Looking Ahead

Global-first milestones are ultimately the result of preparation, collaboration, and effective execution. In this study, Profound’s embedded cardiology model enabled the research team at Southern California Heart Specialists and Dr. Giesler to prepare before activation, identify appropriate candidates, and move quickly once the site was ready.

The result—First Patient Screened Globally and First Patient Randomized Globally—demonstrates how close collaboration between experienced investigators and integrated research teams can help accelerate enrollment and move cardiovascular research forward.