As part of the 2016 21st Century Cures Act, the FDA allowed companies to provide "data summaries," real world evidence, and anecdotal data to support approval of new indications, including a required statement on patient experience data. That reflects a growing number of patients who want their voices to be heard, from trials to treatment plans.
IQVIA can help you meet those expectations and make the patient experience a meaningful measure of therapeutic value.
Our solutions are designed to dovetail with existing internal capabilities, so from strategy development to regulator and payer communications, you have what you need to amplify the patient perspective.
Widespread use of mobile devises is bringing patients closer to trials than ever before, from enabling remote recruitment to giving patients an "always on" way to report information about symptoms and quality of life.
IQVIA's e-Clinical Outcome Assessment (eCOA) seamlessly integrates self-reported data from patients into the overall endpoints reporting process. So internal and external stakeholders can seamlessly extract insights from traditional and digital data.
Beyond meeting regulatory and payer asks, taking patient feedback into account can change the way your trials work, and the quality of your outcomes. Listening to patients can give you a different point of view on what constitutes better treatment. So you can design trials that respond to what patients value, and get to better treatments faster.
That in turn can support significant differentiation and attendant advantages, both in gaining market access, achieving regulatory acceptance and finding the highest and best applications for your therapy.
Access new resources for advanced therapy development, from candidate identification through market authorization.
Build and compare potential pipeline development strategies quickly and transparently.
Use machine learning-driven analytics to help identify promising patient subgroups, potentially preserving your investment and ensuring valuable therapies reach patients.