Pharmacovigilance
The EU Directive 2001/20/EC requires the sponsor of clinical trials:
- to capture
- to evaluate
- to code
- to report on time
- to document
- to archive
adverse events. Once a year or on demand the annual safety report of the study has to be submitted to the national authorities and national ethics committees.
Our multidisciplinary team offers a range of activities in pharmacovigilance for clinical trials on medicinal products. The activities range from planning and conduct of pharmacovigilance in the study, the performance of reporting and analysis of data. Nature and scope of activities will be agreed upon with the customer. Upon request we provide project-specific SOP.
The pharmacovigilance services of CenTrial GmbH include:
- Adverse Event / Serious Adverse Event Management: collection, recording, documentation, coding, evaluation, review, follow-up
- SAE-processing in our validated pharmacovigilance (PV) system VigilanceONE ®, in the customer's system or another system
- Preparation of Case Narratives
- Preparation and timely reporting of individual cases (e.g. CIOMS I)
- Electronic transmission of individual cases according to E2B on our validated pharmacovigilance system VigilanceONE ®, the customer's system or any other system
- Preparation and timely reporting of annual safety reports
- Notification of the investigator ("SUSAR", "safety letters')
- Comparison of safety data ("Data Reconciliation")
- Continuous monitoring with risk-benefit analysis and safety assessment
- Medical review
- Participation in safety monitoring boards or support function for Drug Safety Monitoring Boards (DSMB)