Medical Monitoring and Pharmacovigilance

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