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The FDA Roadmap enables researchers involved in patient-centric trials to navigate FDA clinical outcome assessment qualification program
Presented by PHT Corporation, the new FDA Roadmap App is the first mobile app designed to help sponsors navigate the Roadmap to Patient-Focused Outcome Measurement in Clinical Trials released by the FDA in conjunction with their Clinical Outcome Assessment Qualification Program. The program and roadmap highlight the process by which a sponsor should consider, choose and or develop a patient-focused outcome measurement strategy in a clinical program. PHT is the leading provider of technologies used to collect patient-driven eData for clinical research.
PHT’s new mobile app optimizes the roadmap for android phones and tablets. You can download the android app and view the mobile web version here: http://www.phtcorp.com/Resources/Apps/FDA-Roadmap-App.aspx or download directly via Google Play: http://bit.ly/PHTs-FDA-Roadmap-Android
Watch a short demo of the PHT Roadmap App here: http://bit.ly/1riBDvc
The purpose of the FDA roadmap is to help trial sponsors improve clinical research that collects patient data through understanding the disease or condition, conceptualizing the treatment benefit resulting in identification of the targeted context of use (COU) and concept of interest (COI) for future clinical trial measurement.
PHT Vice President of Marketing and Product Management Sheila Rocchio, MBA, said, “Clinical trials are including more patient reported outcomes (PROs) since the publication of the FDA Patient Reported Outcome (PRO) Guidance in 2009, PHT has a mission to help researchers capture the voice of the patient and incorporate more patient-driven outcomes into research. This new App makes it easy for clinical research professionals to rapidly and easily reference this new roadmap content. “
The Roadmap App is another example of PHT innovation in mobile technology for clinical research. The PHT LogPad® System which collects compliant patient data using smartphones has been a finalist for the Clinical Informatics Informatics News Best Practices Award and the SCDM Data Driven Innovation Award.
Learn about the latest PRO and eCOA innovations, case studies and best practices at the 2014 PRO & eCOA Congress at bit.ly/CongressBarcelona. Learn more about the PRO & eCOA Congress in one minute: http://bit.ly/1h39AHS