How to Reduce Eligibility Risk and Prevent Protocol Deviations
About this webinar
Enrolling the wrong patients is a serious protocol deviation that leads to costly rework and delays, and increases risk to patient safety, data integrity and regulatory approval. The FDA’s December 2024 draft guidance titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” emphasizes a quality by design approach for preventing protocol deviations. Join this webinar to learn how sponsors, CROs and academic research organizations (AROs) can mitigate risk by applying a quality by design framework at a key focus area highlighted by the FDA: eligibility.
Through best practice and case study data, attendees will gain insight into how centralized eligibility review and structured workflows support protocol-compliant enrollment, strengthen documentation and enable faster, more consistent decisions without compromising quality.
Join industry experts as they share practical strategies to prevent enrollment-based deviations, streamline eligibility decisions, ensure data integrity and enhance patient safety.
Register for this webinar to equip patient enrollment teams with practical strategies to prevent protocol deviations, improve eligibility decision-making and reduce downstream operational risk.
Who should attend
- Clinical Operations Directors, Team Leaders, Trial Monitors
- Expert Panel Operations Leads
- Project and Program Management Directors, Clinical Trial Managers, Trial Operations Program Leaders
- Quality Assurance and Data Compliance professionals
- Medical teams, including Medical Monitors and Advisors
- Clinical Development teams, including Medical Writers
What you will learn
- Identify why eligibility is a high-impact point for deviation prevention
- Drive protocol compliance with centralized eligibility review
- Enable rapid eligibility decisions with clear documentation and oversight
- Use quality by design to protect patient safety and data integrity
Featured Speakers
Catherine Tyner
With 28 years of clinical research experience, Cathy Tyner has led multiple functional departments including clinical safety, 24×7 medical monitoring coordination, vendor management and oversight group management (which encompasses the coordination of clinical endpoint, data, eligibility, and monitoring committees, core laboratories, and other expert panels). Cathy has overseen the delivery of more than 500 clinical trials, including complex megatrials across diverse therapeutic areas. She has made significant contributions to industry thought leadership and best practice guidance throughout her career. Cathy is a seasoned senior business leader who is dedicated to delivering strategic insights and practical, creative solutions in the clinical trial space.
Craig McLendon
Craig McLendon is an adjudication and clinical operations leader with 29 years’ experience overseeing global adjudication, data monitoring committee operations and large-scale clinical trial programs. Most recently, he served as Vice President, Adjudication, Perceptive Inc., where he initiated and developed a new department focused on operational excellence and international project oversight. Prior to Perceptive, Craig was a senior director at ICON plc, leading adjudication and data monitoring committee programs and driving process improvement, quality oversight and compliance across global teams.
Craig is well known for building high-performing teams, strengthening cross-functional collaboration and delivering practical solutions that improve trial execution and outcome.
Partner for this event
AG Mednet
AG Mednet is a leading provider of intelligent technology solutions for clinical trial operations, medical affairs, and safety. Judi, the company’s flagship cloud-based platform, and tailored services, are designed to reduce operational complexity, ensure regulatory compliance, and improve data integrity across global studies, empowering sponsors, CROs, and sites to streamline journeys and accelerate timelines.
With expertise across more than 20 therapeutic areas, including oncology, cardiology, neurology, and rare diseases, AG Mednet has over two decades of experience optimizing clinical trial processes, with trusted, proven use cases for integrated DSMB/oversight management, eligibility assessment, remote monitoring, site and user qualification, 24×7 medical monitoring, and is the industry standard for endpoint adjudication, compliant DICOM imaging collection, storage, and review.
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