Electronic Patient-Reported Outcomes (ePRO) is a growing methodology for providing self-reported patient health status in post-market surveillance (PMS). PRO measures in medical product development must be implemented to support labelling claims. They are measured with specific questionnaires that must meet standards if the data will be used in support of a product labelling claim.
AT offers services for integrating real-time survey systems for electronic Patient Reported Outcomes (ePRO), helping pharmaceutical customers to meet the upcoming compliance requirements for PMS. The questionnaire and study data can be integrated to meet a range of requirements beyond ePRO, bringing not only compliance, but real added value to the manufacturers.
AT has developed a real-time demonstrator system for ePRO that is fully configurable, both as a stand-alone system and integrated into AT’s mHealth solution Zeta, helping to get real-time location and patient context data for a given study. The demonstrator helps our customers to refine their requirements for implementing and integrating an ePRO solution of their own PMS.
Integration & Consulting
We at AT understand both the regulatory requirements as well as the real-world challenges of integrating an ePRO solution into a current working IT environment. We can provide consultancy right at the start, helping with procedures and infrastructure, and we can provide end-to-end services during development and integration of your PMS solution.