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More info about Datapharm Australia

Medical Monitoring and Pharmacovigilance

Datapharm Australia

Our medically qualified personnel are able to offer a wide range of medical monitoring and pharmacovigilance services to support your product development.

  • Respond to trial site queries about eligibility issues or other medical or safety issues arising at the outset and during clinical trials
  • Liaise with and report to DSMB
  • Receive and process SAE forms for clinical trials
  • Report to regulatory authorities as required (TGA, FDA and EMA)
  • Prepare adverse event and serious adverse event narratives, with follow-up until resolution
  • Clinical coding of AE, medical history and medication data (MedDRA and WHODD)
  • Setup and maintain safety database

 

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