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