AMS electronic Patient Reported Outcomes (AMS-ePRO®)
AMS-ePRO® supports Clinical Research
Due to this fact, Clinical Research faces the challenge, how to bind the usage in terms of GCP.
AMS has a 20 year success record of supporting many pharmaceutical, biotechnology and medical device companies in running clinical trials of all phases, indications and complexities. As clinical research evolves, and patient engagement is increasingly important, AMS has developed a fully validated electronic ePRO solution.
AMS-ePRO® system is a fully validated electronic solution which not only conforms with GCP and GDPR, but is flexible and more accommodating for the patients as they can utilize their own device. AMS has successfully utilized AMS-ePRO® in several studies in different indications.
AMS-ePRO® - flexible solutions
Collect what you want!
- Collect Patient Reported Outcomes including
- Patient diaries: simple or complex
- Quality of life or health related quality of life data. QOL, HQRL
- Surveys
- ETc
- further possibilities like Geofencing, site-triggered calls, reminders.
Bring Your own Device – Concept
Internet-based Data Collection with patient own devices for NIS (e.g. smartphones, tablets or computers)
System fully validated
according to international computer system validation
standards (21 CFR part 11 and Annex 11)
System GDPR Compliant
in accordance with the new Data Protection requirements (GDPR)
Reporting
data upload into AMS EDC Data-Base or to reporting platform compatible with all AMS EDC platforms or will integrate into your own reporting platform....again a flexible solution
