What To Know
Drug and patient safety is the overriding mission of pharmacovigilance. The process of revealing and addressing potential hazards in pharmaceutical products allows scientists to ensure efficacy while minimizing the risk of harm.
Many levels of drug and patient safety requirements and activities must be carried out during drug development and marketing. Your team must be prepared to undertake, execute, and prove the safety of new pharmaceuticals to all governing regulatory bodies in your country and wherever the product will be marketed.
Your staffing for pharmacovigilance activities requires specialized expertise in drug and patient safety.
How We Can Help
Contracting dedicated experts gives you confidence that your pharmaceutical product will succeed on time and on budget. Our consultants help make that possible.
I3 Infotek is highly selective in engaging consultants. Your needs will be met with top experts in their fields. We specialize in all drug and patient safety activities, such as those shown.
- Collecting statistical data from clinical and patient sources
- Lab and imaging data analysis
- Medical coding
- Safety monitoring of clinical trials
- Medical and QA review
- Researching and evaluation of inputs and data to prevent or minimize risks
- Manage and prepare reports for regulatory submission
- SAE/AE initial documentation and reporting
- Case Report Characterization
- Epidemiologic input for product reports
- SAE case processing
Please contact us, if you need any further assistance. we can help