Pharmacovigilance Services OCT’s Pharmacovigilance team covers a range of clinical trial safety monitoring and safety reporting tasks and responsibilities for our clients’ studies. We can guarantee that all safety information is collected and reported to the appropriate individuals and organizations within the required timelines on all studies we conduct for our clients.
- Set up of PVG specific processes and procedures
- Evaluation of safety data
- Obtaining data about Serious Adverse Events, description and processing of this data
- Data entry and MedDRA coding
- Medical review, quality control
- Informing regulatory authorities and study sites about the presumed serious and unforeseen adverse reactions
- Preparation and submission of safety reports to regulatory authorities in all countries where clinical trials are being conducted
- Preparation and submission of the Annual Safety Report to study sites
Thanks to the experience of our specialists in the field of Pharmacovigilance and their regulatory insights, we are able to prepare high quality safety reports within the required timelines.