Pharmacovigilance/Clinical Safety - read more

The AMS  Clinical Safety team provides you with the full safety service range or custom-made single service packages according to your needs:

  • Implementation of the EU Pharmaceutical Package (PV-System Audits, data entry of adverse reactions, etc.)
  • Preparation of the Pharmacovigilance System Master File (PSMF)
  • Preparation of Risk Management Plans (RMP)

In case of a temporary or permanent capacity bottleneck of sufficiently experienced staff:

  • Outsourcing of either the entire pharmacovigilance skillset or any single task like:
    • Graduated Plan Officer (Stufenplanbeauftragter, Germany)
    • Qualified Person Responsible for Pharmacovigilance (EU QPPV)
  • Preparation of Periodic Benefit Risk Evaluation Reports (PBRER, formerly PSUR), etc.
  • Implementation and/or execution of clinical safety services for Non-interventional Studies (NIS) and/or Clinical Trials (CT)
  • Support of an investigator regarding an Investigator Initiated Trial (IIT) 

 

Take advantage of AMS  competency and reliability!

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Pharmacovigilance bottom korr

• 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...

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    Artikel vom 01 August 2019 News
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  • EMA-EUnetHTA Parallel Consultation

    EMA-EUnetHTA Parallel Consultation

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    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

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    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...

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    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...