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Global Product Safety
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Working according to the sponsor's needs, Covance provides full safety department services for drugs, biologics, vaccines and devices.
Clinical Trial Safety Services Globally
- Receipt, processing and narrative generation of serious adverse experiences, pregnancies and endpoints
- Databasing in a Covance hosted commercial safety application or remote entry databasing directly into sponsor safety databases
- MedDRA and other dictionary coding
- Medical monitoring
- Reporting to regulatory authorities globally
- Support of Drug Safety Monitoring Committees (DSMB)
- Notifications to investigators.
Post Marketing Services Globally
A. Clinical Trial activities
- Phase IIIb/IV clinical trials
- Post Authorization Safety Studies (PASS)
- Risk management program design and implementation
- Product recall/withdrawal
- Litigation case review and MedWatch generation
- Safety reporting.
B. Spontaneous Reporting activities
- Safety reporting
- Safety database hosting
- Call center services
- Regulatory reporting globally
- Co-suspect notification
- Literature search services
- Co-licensing agreement support
- Periodic report writing (PSURs/FDA PRs) for regulatory submission.
Stand-alone Services
- Clinical Safety
- Pharmacovigilance
- Epidemiology
- Spontaneous reporting
- Product recall or withdrawal
- Periodic safety reporting (PSURs/FDA PRs)
- Narrative preparation
- Legacy safety data entry
- Risk management services.
Why Covance? 6 Great Reasons
- We ensure full regulatory compliance globally. We:
- Continuously review and update regulatory reporting requirements throughout the world
- Adhere to the legal time frames for the reporting of serious adverse event reports
- Offer a fully validated safety database
- Follow and comply with ICH standards including E2A (Standards for Expedited Reporting), E2B (Data Elements for Transmission of Individual Case Safety Reports, E2C (Clincial Safety data Management: Periodic Safety Update Reports for Marketed Drugs), M1 (Medical Dictionary) and M2 (Electronic Standards for the Transfer of Regulatory Information and Data (ESTRI) capable
- Experts in EU Clinical Trial Directive requirements
- Experts in EU requirements for safety reporting
- Experts in U.S. Pre and Postmarketing Adverse Drug Experience reporting regulations and guidelines.
- We offer documented procedures to provide consistent scientifically valid pharmacovigilance data. Our Global Product Safety team works according to global harmonized processes. These processes are documented in our global and local SOPs and ensure adherence to the ICH GCP guidelines, the EU Clinical Trial Directive and local regulations.
- Client satisfaction is our goal. Whether a client trusts us with a new product launch, vintage product safety reporting, 50 reports per year or 500 reports per day, we provide the highest quality safety services available. Every processed event report is quality control checked before it is forwarded to the client.
- We provide epidemiology expertise, trend and signal detection using experienced medical monitors, epidemiologists and software applications. Outsourcing the routine or more administrative safety processing will allow sponsors to focus on trends and signal detection and to complete the safety profile of the product in development on an ongoing basis.
- We offer excellent staff management of resources and systems. Our Global Product Safety team will:
- Handle the resource fluctuations to meet the rate of adverse event reporting
- Provide phone and fax lines for overflow or spikes in reporting
- Build your safety database from your first Phase I study through market approval and post-market spontaneous events
- Backlog safety data entry.
- We have extensive experience in remote data entry to client systems, including experience with:
- ARISg™
- Argus Safety™
- Clintrace™
- Oracle AERS
- Proprietary.
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