Our PRO team includes a number of individuals with extensive experience in the strategic, regulatory and technical aspects of PRO research.

Jane Scott is a former primary Endpoint Reviewer in the Study Endpoints & Label Development (SEALD) Team of the Office of New Drugs, Center for Drug Evaluation and Research (CDER) at the FDA. Jane's primary role at FDA was to provide expert review and consultations to all FDA review divisions in CDER, the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiologic Health (CDRH) regarding the adequacy of proposed study endpoints and their measurement to support statements in labeling and advertising. Her reviews included evaluation of proposed labeling, advertisements, and adequacy of endpoint measures and study designs in more than 200 submissions to FDA. Jane has more than 20 years experience in the development, validation, and implementation of PRO measures in clinical trials.

Patrick Marquis has personally designed, led, analyzed and interpreted over 100 studies with PRO endpoints and is a member of the European Regulatory Issues on Quality of Life Assessment (ERIQA) group and has been a leader of discussions for the ISPOR Quality of Life Special Interest Group. Patrick has submitted data to the FDA and to European regulators, is regularly involved in FDA mock panels and has attended a number of regulatory meetings with the FDA to support clients in their discussions on targeted claims.

Bruce Crawford has been involved in research and training with the FDA. He has helped clients to obtain labeling claims through the development of briefing documents and slide decks for FDA regulatory meetings, and has attended meetings with clients. As well as having almost 10 years experience with Mapi Values, Bruce has worked in managed care and in a major CRO as a health economist.

Kathleen Rosa is a psychometrician specialized in the development, validation and implementation of PROs. Kathleen has 15 years of research experience, some of which was gained in the Biostatistics and Health Outcomes Departments of a major CRO, where her final position was Manager of Health Outcomes. Kathleen has led the development of a number of PRO instruments to be used in clinical trials to support labeling claims with the FDA.

Kathy Lasch has worked for many years researching the influence of various factors on health and medical care delivery, with a special focus on pain and other Health-Related Quality of Life issues. She has extensive experience and state-of-the-art knowledge in the conduct, analysis, and write-up of qualitative research.

Linda Abetz has worked for more than 15 years in PRO consulting, with more than 10 of these spent at Mapi Values. She has designed and led numerous international projects to develop and validate PRO measures and analyze their results from clinical trials. Linda has conducted numerous training sessions on PRO methodology and lectures on the application of PRO research.

Benoit Arnould has conducted numerous studies to develop and validate PRO measures in a variety of conditions. Benoit has been involved mainly in projects related to the use of PRO instruments for individual clinical decision making and patient management. Benoit is now responsible for a Mapi Values Unit dedicated to the development, validation and use of specific Patient Scales for Clinical Practice.