Global Product Safety
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Protecting the health and safety of patients is paramount. Covance delivers superior quality safety services and expertise worldwide.
Our Global Product Safety team provides a variety of comprehensive services, including and managing the following programs:
- Drug safety
- Biologics safety
- Device safety
- Vaccine safety
- Pharmacovigilance
- Safety surveillance
- Pre-marketing, clinical trial safety
- Postmarketing safety including Spontaneous and literature reports, postmarketing surveillance studies
- Databasing
- Risk management
- Crisis management/product recall/withdrawal and safety litigation
- Trend and signal detection.
Our teams are located in three regions — the Americas, Europe and Asia-Pacific — and operate with single, global management and common SOPs.
Our dedicated pharmacovigilance staff members bring in-depth experience of safety reporting in clinical studies and post-marketing surveillance. Our staff members have experience in safety, clinical research, data management and regulatory affairs. They have life science degrees, including nursing, pharmacy, medical technology and other related qualifications.
Covance has provided safety services, in conjunction with clinical trial conduct, to the pharmaceutical industry for over 20 years. In 1997, pharmacovigilance services were expanded to include spontaneous reporting, product recall services, periodic report generation (FDA Periodic Reports (PRs) / Periodic Safety Update Reports (PSURs) and other specific safety-related services, not necessarily associated with a clinical trial. |
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