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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Datamanagement

• 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

News

  • EUnetHTA publishes the second iteration of the EUnetHTA Prioritisation List (EPL)

    EUnetHTA publishes the second...

    Information
    Artikel vom 01 August 2019 News
    It’s time to get involved: EUnetHTA publishes the second iteration of the EUnetHTA Prioritisation List (EPL) EUnetHTA’s Joint Action 3 will definitely end in...
  • EMA-EUnetHTA Parallel Consultation

    EMA-EUnetHTA Parallel Consultation

    Information
    Artikel vom 01 August 2017 News
    Profit from the simultaneous feedback of regulatory and HTA bodies in order to generate your data set in the most efficient way! What is new? EMA and EUnetHTA have...
  • AbbVie TRIUMPH AWARD 2015

    AbbVie TRIUMPH AWARD 2015

    Information
    Artikel vom 24 June 2016 News
    Um Kooperationen auszuzeichnen und Partner entsprechend zu honorieren, verleiht AbbVie Global jährlich den Preis 'Supplier of the Year'. Kriterien, um für den...
  • AMS electronic Patient Reported Outcomes (AMS-ePRO®)

    AMS electronic Patient Reported...

    Information
    Artikel vom 01 June 2016 News
    AMS electronic Patient Reported Outcomes (AMS-ePRO®) AMS-ePRO® supports Clinical Research You can now capture your patients data Anytime Anywhere with...