Meeting your post-marketing pharmacovigilance, clinical study safety, or device vigilance obligations is a key requirement for your business. Does your company have the resources and know-how needed to continuously monitor the safety profile of your company’s products?
Don’t worry, we can help you. Our pharmacovigilance team consists of highly dedicated, professional and experienced members from both the pharmaceutical industry and the CRO business. Our processes are fully compliant with local and international regulations and guidelines, and we work with a fully validated, ICH and FDA 21 CFR Part 11-compliant safety database.
Our pharmacovigilance team are specialised in providing drug/patient safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies.
We offer a full-service pharmacovigilance solution, acting either as your safety department or as reinforcement to your presented pharmacovigilance team.
We offer our services both during clinical development and post-marketing. They can be provided as a complete solution or as stand-alone services.
- Pharmacovigilance System
- Detailed description of the pharmacovigilance system
- Standard Operating Procedures (SOP’s)
- Safety Database
- Safety Data Exchange Agreement
- EU Qualified Person for Pharmacovigilance (QPPV)
- EU depute QPPV
- 24/7 Medical support
- Operational Services
- Case handling (triage) of adverse events (AE) and adverse drugs reaction (ADR’s) during clinical development and post-marketing
- Periodic reports (PSURs/PDERs/DSUR)
- Medical literature search
- Generation of CIOMS I/ MedWatch forms
- Expedited reporting till Eudravigilance
- Call center services that handle medical information, and AE/SAE case intake
- Specialist services
- Risk Management Plan (RMP)
- Risk Benefit Analysis
- Signal Detection (analysis and trending of cases)
- Signal Evaluation
- Support Services
- Corrective And Preventative Actions (CAPA)
- Outsourcing of pharmacovigilance consultants