Adherence is one of the most persistent challenges in CNS trials, particularly in studies involving controlled substances. This webinar examines how a Phase II study in major depressive disorder (MDD) addresses this issue directly, utilizing a digital, patient-centred solution.

The SOLEO trial, an ongoing Phase II study evaluating oral esketamine (CLE-100), integrates Scene Health’s Video Directly Observed Therapy (VDOT) Adherence Service to support daily patient compliance. Using asynchronous video capture and real-time human review, the system enables the timely identification of missed doses, potential misuse and patients at risk of dropout — ultimately improving protocol adherence, medication accountability and patient retention.

Drawing on operational insights from the trial site, sponsor and technology provider, this case study highlights practical considerations for implementing a tech-enabled adherence model in CNS trials. It also examines how digital health tools can enhance data integrity, reduce protocol deviations and support more efficient therapeutic development.

Featuring a panel of experts from the trial site (a Clinical Trials Manager, CenExel Research), the pharmaceutical sponsor (Medical Director, Clexio Biosciences) and the technology provider (Chief Strategy Officer, Scene Health), this session offers a valuable perspective for medical directors, trial operations leads and innovation officers at pharmaceutical companies and CROs.

Join the featured speakers to explore how:

Digital adherence tools are being used in real-time to improve protocol compliance and reduce patient dropout in CNS trials
A human-in-the-loop review model can detect and escalate non-compliance faster than traditional methods
Understanding the patient experience with digital tools can improve engagement and long-term retention
Technology-enabled adherence services can reduce protocol deviations and support more reliable data

Register for this webinar now to gain a comprehensive understanding of how digital health solutions are reshaping the landscape of CNS trials, delivering more reliable data, enhancing patient safety and driving greater overall trial success.

Keywords:

Speakers

Esther Hagai, MD, PhD, Chief Medical Officer, Clexio Biosciences Ltd.

Dr. Esther Lukasiewicz Hagai is a drug development expert with over two decades of experience in the pharmaceutical and biotechnology industries. For the past six years, she has served as the Chief Medical Officer at Clexio Biosciences, with a focus on neurology and psychiatry.

Before joining Clexio, she served as the VP of Clinical and Regulatory Affairs at Pluristem, where she developed placental cell therapies. Dr. Hagai also spent four years at Teva Global R&D as Director and Clinical Program Leader, overseeing global clinical programs for biosimilars and innovative drugs in oncology and neurology.

Morgan Hecker, Clinical Trials Manager, CenExel iResearch Atlanta

Morgan Hecker is a dedicated clinical research professional with over seven years of site-level experience as a Clinical Research Coordinator, specializing in central nervous system (CNS) studies, with a strong focus on Alzheimer’s disease and psychiatric disorders. She currently serves as a Clinical Trials Manager at CenExel iResearch Atlanta, where she leads and supports complex clinical trials with a commitment to quality, efficiency and patient care.

Morad Elmi, Co-Founder, Chief Strategy Officer, Scene Health

Morad Elmi is Co-Founder and Chief Strategy Officer of Scene Health, a digital health company providing nurse-led observed dosing to improve adherence and retention for clinical trials, public health departments and health plans. He leads all life sciences research and public health initiatives.

Morad has over a decade of experience designing and implementing digital health solutions for clinical trials, research and government agencies globally, as well as supporting patients with chronic and infectious diseases while increasing efficiencies in healthcare organizations.

Who Should Attend?

This webinar will appeal to professionals in these departments and roles:

Clinical Operations
Digital Innovation/Strategy
Patient Experience
Medical Directors
Decentralized and hybrid trials
Clinical Trial Management

What You Will Learn

Attendees will learn:

How dose-by-dose adherence monitoring with digital tools and timely interventions can significantly increase patient retention and improve overall compliance in CNS trials
How active, daily adherence monitoring with a built-in review service offers advantages over traditional adherence solutions
The real-world challenges that patients face in adhering to protocols, managing medication and using digital tools. This perspective is crucial for understanding the “human element” of adherence
How a technology-enabled service can improve trial efficiency and strengthen confidence in data integrity

Xtalks Partner

Scene Health

Scene Health addresses the long-standing challenges of medication adherence and patient retention through a blend of human expertise, proven science, and innovative technology. Our nurse-led, directly observed dosing service enhances medication compliance and improves patient retention in clinical trials, delivering more reliable data and accelerating the approval of life-saving treatments. Our platform’s patient-centered approach empowers sponsors to engage a broader, more diverse patient population, all while minimizing site burden with continuous support. Established in 2008 out of Johns Hopkins University, Scene Health has partnered with over 700 clients and is clinically proven to boost adherence and outcomes across the healthcare ecosystem.

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CNS Trials: Lessons in Adherence Monitoring from a Phase II Study

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