Case Study: Exceeding Enrollment Goals by 200% in a Phase III Multiple Sclerosis Trial
How targeted EMR pre-screening, investigator engagement, and proactive study coordination helped drive enrollment in a complex relapsing multiple sclerosis trial
Clinical trials for relapsing multiple sclerosis (RMS) can present significant recruitment and retention challenges. Strict eligibility requirements, washout periods for prior therapies, detailed safety screening, and an intensive schedule of study visits can substantially narrow the pool of appropriate participants and increase the complexity of enrollment.
For one global Phase III program, those challenges were compounded by an accelerated startup and recruitment timeline.
Leveraging Profound Research’s embedded model within neurology practices, direct EMR access, and protocol-specific pre-screening, the site was able to identify appropriate patients early and proactively coordinate the complex requirements of the study.
The result: the site became the first to screen a patient, the first to enroll a patient, and ultimately exceeded its enrollment goal by 200%.
The Challenge: Complex Eligibility and an Intensive Study Schedule
Identifying appropriate participants for this RMS study required navigating a demanding set of protocol requirements.
Potential participants needed to meet strict inclusion and exclusion criteria while accounting for washout periods associated with prior therapies and completing detailed safety screening. Once enrolled, participants faced an intensive schedule that included frequent study visits, pharmacokinetic (PK) sampling, MRI assessments, and ongoing safety monitoring.
Together, these requirements made identifying, enrolling, and retaining appropriate participants particularly challenging—especially within the sponsor’s accelerated startup and recruitment timeline.
Success required more than access to a large patient population. It required the ability to identify the right patients efficiently and prepare both the research team and participants for the demands of the protocol.
The Solution: Targeted Pre-Screening and Proactive Coordination
Profound’s embedded neurology model allowed the research team to work within established neurology practices and use direct EMR access to conduct targeted pre-screening aligned with protocol-specific criteria.
This approach enabled the team to identify potentially eligible RMS patients early and prepare for screening and baseline visits in advance.
Screening and baseline visits could be pre-scheduled, while protocol-required assessments—including PK sampling and safety evaluations—were coordinated proactively. By anticipating these requirements rather than addressing them sequentially, the team streamlined enrollment and helped reduce screen failures.
Strong investigator engagement further supported execution, combining clinical knowledge of the patient population with an integrated research team prepared to manage the study’s complex procedural requirements.
The Outcome: Enrollment Goal Exceeded by 200%
The combination of targeted patient identification, investigator engagement, and proactive study coordination translated into strong enrollment performance.
Key Milestones and Achievements:
- Site Activation: May 23, 2025
- First Site to Screen a Patient
- First Patient Enrolled: June 10, 2025
- First Site to Enroll a Patient
- Enrollment Goal Exceeded by 200%
Beyond enrollment, the site efficiently executed complex study procedures and maintained high-quality participant management throughout the trial, positioning Profound Research as a top-performing site within the global Phase III program.
What This Means for Sponsors
Complex neurology trials require more than patient access. They require sites capable of translating that access into qualified participants while managing demanding protocol requirements efficiently and maintaining a high-quality patient experience.
This case demonstrates the value of combining protocol-specific EMR pre-screening with embedded research operations and engaged investigators. Early identification of potential participants allowed the team to prepare for screening and coordinate required assessments proactively, helping reduce screen failures and maintain momentum throughout recruitment.
For sponsors, this model can help address one of the central challenges of complex neurology research: finding appropriate patients efficiently while maintaining the operational rigor required by the protocol.
Looking Ahead
Strong enrollment performance begins well before a patient enters a study. It requires access to the right patient population, an understanding of protocol-specific requirements, engaged investigators, and research teams capable of anticipating what comes next.
In this Phase III multiple sclerosis program, those elements helped the site achieve the first patient screened, first patient enrolled, and an enrollment result that exceeded its goal by 200%.
The outcome demonstrates how Profound’s embedded research model can help turn patient access into meaningful study progress—supporting sponsors, investigators, and ultimately the patients who depend on continued advances in multiple sclerosis research