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

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