Nadine McGale's Contact Details

Nadine McGale's Company Details

Modus Outcomes

Cambridge, MA, US • 50 - 99 Employees
Major Drugs

Concept-Driven Measurement™ for High-Stakes DecisionsModus Outcomes is an international company based in the US, the UK and France providing consulting services to measure the benefit and clinical values of medical products using COAs. Our unique approach is characterized by a conceptually-driven measurement anchored in the experience of patients, the clinical relevance and hierarchy of the concepts, and a stochastic measurement model. We integrate clinical, regulatory, and measurement perspectives at all phases of design and evaluation. Our distinctive process is grounded in qualitative-quantitative mixed methods for efficiency and accuracy. Our approach is simple yet rigorous.We work with you to ensure that you measure the right things well in order to maximize the success of your clinical programs.Our services:• Comprehensive advice and support for strategic plans to evaluate the benefit of treatment from the patient perspective• Development of de novo COAs that maximize the chance of detecting meaningful treatment benefit supporting regulatory and promotional claims• Troubleshooting legacy or ad hoc questionnaires to de-risk clinical programs using COAs• Adaptation of existing questionnaires to a new context of use• Design and execution of pre-specified and post hoc advanced analytical plans for inclusion in CSR and scientific communication• Training on cutting edge mixed-method COA development and validationBy creating Modus Outcomes, a Center of Excellence for the development of Clinical Outcomes Assessments, we set new standards in measurement.