Pharmacovigilance
The Cornerstone for Risk Management
CDSS can provide a full range of Pharmacovigilance and Risk Management (PVRM) services for all study phases ensuring drug safety standards are being performed to the highest current standards on a regular basis.
Activities can include:
- Protocol review and PV activities, including subject safety
- Collating, reviewing and reporting Adverse Events (AEs)
- Periodic reporting of collated AEs
- Writing and submitting safety updates to ethical and regulatory authorities
- Expedited reporting of suspected unexpected serious adverse reactions (SUSARs)
- Writing and reviewing PV sections of study reports
- Provide a seamless approach to drug safety for products undergoing both clinical and post-marketing assessments
