Journal of Alzheimers Disease & Parkinsonism
Open Access

Abstract

Epilepsy is a complex disorder, noted for its heterogeneous and unpredictable manifestation which can amplify diagnostic uncertainty. This can be exacerbated by variability in access to diagnostic methods and site personnel experience with various epileptic syndromes. Even when the clinical diagnosis is accurate, seizure frequency is notoriously difficult to measure reliably and even more problematic to assess in pediatric epilepsy trials. These concerns are intensified when trials are performed on a global scale and across numerous study centers that conduct neurological clinical trials in multiple indications. I will discuss how Syneos Health can help minimize the risk of these issues through the use of our Clinical Surveillance and Training (CST) team. In addition, Syneos Health can offer additional value propositions regarding the next stage in clinical development – commercialization. Research indicates that 75% of products across various indications that reach the market are commercial failures because they lack integrated planning across the clinical and commerical continuum. At Syneos Health-the industry’s only biopharma accelerator, we understand the worldwide gold standard for solving intricate problems and optimizing opportunities, thereby ensuring that promising compounds have the important support in order to make it to market. Clinical Surveillance & Training has over twenty years of experience working in clinical trials and works to streamline efficiencies to address data impacting errors discovered during seizure diary review processes, thereby helping to increase the likelihood of commercial success in Epilepsy Trials.

Biography

Sharon Fernando is a US trained clinical psychologist with extensive experience in Primary Care facilities, multidisciplinary practice and most recently with the Industry’s only biopharma accelator. Dr. Fernando graduated with her Psy.D. from the Florida Institute of Technology with a specialization in pediatric clinical psychology. Fernando has more than six years of experience with Syneos Health and her current role is as a Senior Clinical Scientist within CST. She provides scientific oversight and clinical guidance for projects within CST and interacts with senior management, customers, and project teams to ensure scientific integrity and data quality in clinical trials. Dr. Fernando is also called upon to provide scientific input as needed to projects outside CST and contribute to business development activities with direct line management and mentoring responsibilities. Her therapeutic areas include CNS related studies.Having lived across three continents, Dr. Fernando's intimate knowledge of interacting with diverse populations makes her especially well suited to understanding and respecting cross cultural differences in clinical trials.