Pharmacovigilance & Risk Management
An accurate and comprehensive pharmacovigilance system throughout the clinical and post-marketing phases is essential for the protection of patients and public health. New directives and regulations that have been implemented to enhance patient safety monitoring can require significant additional resource, time and expertise.
Aptiv Solutions offers comprehensive global pharmacovigilance and risk management solutions to ensure that products comply with these increasingly stringent safety requirements. These solutions encompass the full product lifecycle, from initial clinical trials through post-market surveillance and risk management and minimization plans – including signal detection and trend analysis to identify and address safety across studies and integrated total safety management.
- Global PV platform, supported by highly skilled technical & medical affairs team
- Clinical & Post-Marketing systems & processes
- Customized, detailed safety management plans & protocols
- Regulatory reporting, including E2B reporting
- EU QPPV; Eudravigilance registration & management
- Complete Data Monitoring Committee (DMC) management
- SAE management consistent with GCP & ICH expectations
- Aligned clinical & safety databases