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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• 2011 – AMS AMNOG Services pioneer • 2013 – AMS-Investigator SELF-TRAINING PORTAL • 2013 – “BEST CRO” by one of ther world’s Top 5 Pharma companies’ CRO Evaluation for AMS – Clinical Operations Services • 2014 – AMS performs Medical App Studies including eCRF-data integration • 2015 – AMS Medical Science is awarded “Provider of the Year, worldwide” the world’s Top 10 Pharma companies • 2015 – AMS develops an E-feasibility tool • 2015 – Innovative Tool for Patient Reported Outcomes: AMS-ePRO (BYOD-type PRO solution) is developed • 2016 – AMS – Regulatory Affairs is nominated on the short-list for TOPRA Award for Regulatory Excellence


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