The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments
in clinical evaluation of their products. The guidance details such topics as modification or
adaptation of existing PRO instruments as well as the possibility of including patient-reported
outcome instruments within real-world data sources.
As explained by the FDA in the draft guidance, PRO instruments “facilitate the systematic collection of how patients feel, function and survive as valid scientific evidence to support the
regulatory and healthcare decision-making process.”
Catchtrial ePRO App
OUR Catchtrial ePRO App facilitates better interaction between the patient, investigator and
sponsor, ensures faster trial completion, and significant cost savings. It works with any desktop
or mobile device, including Android and Apple iOS. ePRO simply allows you to stay
tuned with patient health.
ePRO App features
• Manage images transfer in the virtual trial thanks to smartphone camera control
• GDPR and HIPAA compliant – no patient PHI entry required, no personal data breach
• Off-line data entry in case of no internet connection
Catchtrial electronic Patient-Reported Outcomes (ePRO) is a survey of the status of a patient’s
health that comes directly from the patient, i.e. the patient reports the data directly.
These surveys can include psychological symptoms, patient diary and general quality of life
measures, such as how the condition impacts a patient’s daily life.
Learn more about Catchtrial ePRO App!
For more details, please see the guidance from the FDA.
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