Services
The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfill the stringent obligations. Accovion’s Pharmacovigilance team is comprised of healthcare professionals with vast experience in both direct patient care and industry-specific pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services.
Clinical trial safety
- Serious adverse event (SAE) management including collection, documentation, active query process and follow-up
- SAE processing within required timeframes in either a client's database (e.g. Clintrace™ and ARISg™) and other non-commercial systems or in Accovion's global safety database Argus Safety™
- Qualified medical review of all SAEs for data completeness and medical sense
- Appropriate Medical Dictionary for Regulatory Activities (MedDRA) coding
- Regulatory reporting to authorities, investigators and ethics committees
- Electronic safety reporting according to ICH E2B
- Preparation and submission of annual safety reports (ASRs)
- Data reconciliation of pharmacovigilance and clinical trials databases
- Writing of patient safety narratives for study reports
- Project-specific standard operating procedures (SOPs)
- Compliance monitoring
- SAE training for investigators and monitors
Post marketing safety
- Processing and reporting of adverse drug reactions (ADRs) from the post marketing area
- In Accovion’s global safety database Argus Safety ARGUS Safety™
- In client‘s database via remote access
- Electronic safety reporting according to ICH E2
- Compliance monitoring
- Preparation of periodic safety update reports (PSURs)
- Evaluation of signals with respect to the need to update the Company Core Safety Information (CCSI)
- Periodic signal detection activities for medicinal products with a marketing authorization
- Literature review in collaboration with a dedicated literature service provider
- Preparation and Update of risk management plans (EU-RMP)
Dr. Susanne Kaiser
Director Pharmacovigilance
+49 6196 7709-292
