Data Management - read more

AMS  follows the CDISC data standards, for the collection of data according to CDASH and for analysis and submission of data according to ADaM and SDTM.

AMS  uses the clinical database management system (CDMS) / Electronic Data Capture (EDC) System Clincase ® for both EDC and paper trials. The system offers integrated modules for standard DM status reports, eFeasibility, eLearning and eRandomization.

In addition AMS  has developed an electronic Patient Reported Outcome system (AMS -ePRO ) for the online collection of patient questionnaires and patient diaries allowing direct entry by patients themselves using their own devices (any type of smartphones, computers, iPads, etc.).

For coding with MedDRA and WHO Drug Dictionary AMS  uses the PACE ® system from Clearight ®.

AMS  Validation Managers with in-depth know-how in the field of Computer System Validation (CSV) ensure installation and use of AMS  fully validated 21 CFR part 11 compliant systems in Data Management.


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• 2022 – AMS are CTR- and MDR ready • 2022 – New unique AMS-ePRO® features launched • 2022 – Real-World Evidence focus in AMS Late-Stage Research • 2022 – AMS expanded its global reach • 2021 – DIGA dossier submission pioneer •