Helen heads the Clinical Outcomes Assessment (COA) team at Clarivate and has 14 years’ experience of developing patient-reported outcomes (PROs) and other COAs for clinical trials in line with regulatory (FDA, EMA) requirements. Helen has developed and validated multiple COAs for clinical trials and clinical practice. Helen specializes in COA reviews according to regulatory (FDA/EMA) requirements and qualitative research methods using creative, patient-centered techniques. Helen has conducted concept elicitation and cognitive debriefing interviews with patients and clinicians in multiple therapy areas with extensive experience in women’s health and dermatology. She is an active member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and International Society of Quality of Life (ISOQOL) and a specialist trainer in qualitative interviewing skills, mixed methods research and PROs for HTA/reimbursement.
Helen previously held an academic research post at the University of Manchester, developing and validating a PRO measure for the clinical management of psoriasis. Previously, Helen was a Project Manager at Adelphi (MAPI) Values where she worked for four years in the Endpoint Development and Outcomes Assessment team. Helen has an MSc in Health Psychology from Sheffield Hallam University and a BA (Hons) in Psychology from the University of Manchester.