Safety and pharmacovigilance (PV) are paramount in clinical research and development. At times, even the best safety teams may benefit from additional support as they work to meet demanding clinical safety requirements and ensure the integrity of their development program.
Our pharmacovigilance consultants and specialists work with our regulatory and medical writing teams to provide short-term and limited-scope services with the flexibility your organization needs.
Consulting services include:
- Aggregate report writing
- PV SOP and procedure writing
- Risk management plans
- Literature searches and reports
- Inspection readiness audits
- Preparation of reference safety information
- Risk/benefit statements
- Medical review of individual case study reports
- Signal detection
- General consulting and regulatory advice
