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Postmarketing Surveillance
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| Safety Surveillance |
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| Design and conduct safety surveillance studies |
Assist with crisis response & management |
Manage spontaneous AE collection |
| Direct safety surveillance support |
Train personnel in AE reporting regulations |
Perform epidemiologic evaluations of safety data |
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Pharmaceutical companies have an enormous responsibility to ensure the safety of those who use their products. Covance has vast experience assisting clients with postmarketing safety surveillance programs. We even have supported first-time single product launches, and we have handled all safety-related activities for multiple product lines with established products.
Design and Conduct of Safety Surveillance Studies
Covance has designed and managed numerous safety surveillance programs for more than 20 years. A dedicated project team will work with you to plan the best trial that will quantify adverse event (AE) incidence rates, identify rare events and describe the product safety profile.
Spontaneous AE Report Collection, Processing and Regulatory Reporting
Covance manages spontaneous AE reporting systems. Each program is customized and can include any or all of the following:
- Receiving AE reports from healthcare professionals and from consumers
- Triaging other calls such as product complaints back to the client site
- Preparing data for inclusion in periodic safety update reports.
Crisis Response/Crisis Management
Covance will work with you to prepare crisis management strategies. These strategies allow rapid response during periods of stimulated AE reporting or product withdrawal. Activities have ranged from preparation of standard responses for healthcare professionals or consumers to the proactive epidemiologic evaluation.
On-Site Safety Surveillance Support
Covance provides medically qualified staff directly to clients to assist in safety surveillance efforts. Our staff members assume a variety of responsibilities, including:
- Providing medical review and processing of expedited FDA 3500A and CIOMS I reports
- Reviewing legal briefs to identify possible serious events
- Answering telephone calls from healthcare professionals and consumers.
Epidemiologic Analyses
The epidemiologic components of a surveillance program can include strategies for signal detection, analysis of external data sources and registries for continuous safety monitoring of one or more of your products. |
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