Evolving regulatory requirements to place patients at the centre of the drug development process demand design of patient-centred clinical trials. 

ICON Outcome Measures service aims to drive forward patient-centred treatments while helping sponsors increase the likelihood of regulatory approval. By focusing on outcomes that matter to patients and addressing real-world concerns, patient-centred research can produce more compelling evidence for regulators to consider when evaluating a new treatment. This approach not only increases the chances of approval but also helps ensure that approved treatments will provide meaningful benefits to patients in practice. 

Increasingly sponsors want to develop endpoints assessments based on combined clinical outcome assessments (COAs) and digital health technologies (DHT) data to enable more optimised protocol and patient-centric study designs. ICON Outcome Measures offers a full-service approach to support sponsors in the identification, selection and implementation of measures that matter to patients, from phase 1 through regulatory approval. 

We have the capability to advise you on the optimal COA strategy for your study and drive operational delivery of integrated end-to-end solutions that incorporate the selection of actively and passively collected COAs, eCOA technology, COA licensing and distribution, and language services. 

Our suite of capabilities also includes regulatory and advisory consulting, technology tools, data and services to support sponsors in making evidence-based and informed decisions on protocol design to reduce patient burden, increase engagement and enhance data quality. 

ICON’s patient centred outcomes expertise spans four decades of innovation and research on directly engaging with patients across the entire healthcare landscape and through the entire treatment lifecycle. We have experience in delivering services for pharma and biotechnology organisations, academic research institutions, non-profit organisations and health care companies.