Apices provides a comprehensive range of pharmaceutical services, from one single support to your pharmacovigilance department to fully outsourcing the pharmacovigilance sponsor responsibilities in line with the latest international and national regulations.
Although we have internal audited standard operating procedures, we can also work with those of the client if required.
The pharmacovigilance services we offer include: pharmacovigilance training, pharmacovigilance databasing, serious adverse event (SAE) reception, case assessment (eg. causality, expectedness), Qualified Person Responsible For Pharmacovigilance (QPPV) status, risk assessments, development safety update reports, CIOMs writing and expedited reporting.