Ergomed established its clinical safety system in 2004 using the ARISg safety database combined with the extremely strong medical expertise within the company. Clinical safety assignments for many Phase I – IV trials have been managed across multiple indications. A team of highly trained and experienced staff perform data entry, data review and medical review functions.
The team is supported and monitored by the best international industry drug safety and regulatory consultants all of whom have many years’ experience of European authorities and FDA interactions. Ergomed has selected the ARIS-g safety database as the information technology platform of this unit, a fully validated, industry-standard database created for SAE management, reporting and regulatory reporting (including E2B); the web-based system allows maximum flexibility.
In addition, Ergomed’s sister company PrimeVigilance www.primevigilance.com provides specialized post-marketing pharmacovigilance services and expert consultancy advice across the whole drug safety spectrum.