When studies go off track, whether due to operational hiccups, compliance nightmares, or data disasters, how do you bring them back from the brink? Don’t miss NAMSA’s special webinar where a panel of clinical experts share real-life rescue stories and the strategies that saved troubled trials. Our panelists will recount their experiences with troubled trials, reveal the root causes, and discuss the strategies that turned potential horror stories into successes.
Key Learning Objectives:
- Spot Early Red Flags: Identify early indicators of studies at risk: monitoring turnover, inconsistent data, compliance gaps, and recruitment challenges.
- Master Proven Rescue Tactics: Discover proven approaches for rescuing studies, drawing on the expertise of study management, data management, study design, and biostatistics.
- Prevent Future Nightmares: Take away practical advice for preventing rescue scenarios, managing transitions, and ensuring study success, even when things get scary.
Reserve your spot today and turn your clinical horror stories into success stories!
Speakers
Wendy Schroeder, BSN, CCRC/PM, CRCP
Principal Strategy Consultant, Clinical
Wendy has been involved with research and clinical trials for more than 25 years. She has clinical trial execution experience and as a NAMSA consultant supports medical device product development including clinical strategy interactions with the FDA. Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.
Director, Global Strategy Services
A recognized expert within the medical device industry, Chris is highly skilled in biostatistics, scientific communications and regulatory meetings. Chris is experienced with an array of different technologies and therapeutic/diagnostic areas, including cardiovascular disease, gastroenterology, neuromodulation, neurology, oncology, ophthalmology, orthopedics, pain medicine, respiratory/sleep medicine and urology. He has participated in over 200 FDA meetings, including more than 25 FDA Advisory Committee (Panel) meetings. Chris has also helped dozens of global manufacturers understand and translate complex ideas and data into simple and convincing concepts, leading to successful regulatory, scientific and business outcomes. He has been instrumental in bringing many novel products to market.
Clinical Study Manager
Heather has been involved with clinical trials for 22 years. She served as the director of clinical research at a hepatology center managing the execution of clinical trials for nearly a decade. As a Clinical Study Manager at NAMSA, Heather manages all aspects of clinical trials, working closely with cross-functional teams to ensure trial timelines are met. She has experience in a variety of therapeutic areas including hepatology, infectious disease, cardiology, neurology, orthopedics, and wound care. Heather earned a Doctor of Philosophy in Nursing Science from the University of North Carolina at Greensboro and a Master of Science in Nursing from Queens University of Charlotte. She has published manuscripts and abstracts in peer-reviewed journals.
Principal Clinical Database Developer
Jill is an experienced clinical research professional specializing in database development and data management for global clinical trials. At NAMSA, she designs and builds eCRFs, edit checks, and validation scripts across multiple EDC platforms, including Medidata Rave, iMedNet, and Merative Zelta. Jill’s expertise includes protocol design, centralized data review, and database migrations, ensuring accuracy and compliance throughout the study lifecycle. With a strong background in clinical operations and regulatory affairs, she has contributed to studies across diverse therapeutic areas including cardiovascular, gastroenterology, pain management, and diagnostics. Jill holds an M.S. in Pharmaceutical Chemistry from the University of Florida.
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This is a free educational webinar.
