Developing an Observer-Reported Outcomes Measure (ObsRO)

Beverly is a senior outcomes researcher in ICON’s, Gaithersburg, Maryland office. She has worked in the field of Clinical Outcomes Assessments (COAs) since 2010, starting with Oxford Outcomes, which was acquired by ICON in 2011. Beverly is an experienced project manager and qualitative researcher with experience in developing ObsROs as well as adult and pediatric PROs.  She has also been involved in large, multinational conjoint, survey, and interview studies. She has worked in a variety of disease areas and populations: pediatric and adult ADHD, pediatric and adult ulcerative colitis, multiple sclerosis, non-small cell lung cancer, type 2 diabetes mellitus, and pediatric and adult CSID. Beverly has a master’s degree in English and a background in teaching and communication.

Emuella Flood is a Senior Principal in ICON Clinical Outcomes Assessment (COA) and leads the US East Coast COA team in Gaithersburg, Maryland. She began her career in COA research consulting nearly 20 years ago and has been with the ICON team since 2011. Emuella has directed the development and/or validation of PROs, ObsROs and ClinROs, as well as patient preference, conjoint and satisfaction surveys and patient-reported burden of illness surveys for adult and pediatric populations. She has extensive experience in qualitative research and has presented on best practices at industry conferences, including ISOQOL and ISPOR.  She attends FDA meetings on behalf of sponsors in support of COAs used as key trial endpoints and the basis for labeling.  Emuella is on the editorial board of The Patient, leads the DIA Study Endpoints Educational Series Committee, is co-chair of the ISOQOL Industry Advisory Special Interest Group and is a member of the Patient Preference Methodology working group of the Medical Device Innovation Consortium (MDIC).  She has contributed to over 80 peer-reviewed publications and abstracts.