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PHARMACOVIGILANCE FACTS
About Sentrx
 Drug safety experience across product life cycles of diverse healthcare companies
- Investigational new drugs, prescription products, imaging agents, over-the-counter products, and consumer packaged goods
- Top 10 global, mid-size and small companies
- Biopharmaceutical, specialty, generic, medical device and dietary supplement companies
Core competency in pharmacovigilance and risk management
- 100% of revenues derived from drug safety activities
- More than 100,000 post-marketed adverse events and clinical trial SAE reports processed
- Nearly 100 periodic reports and PSURs prepared annually
Depth and breadth in operations
- Coding in MedDRA and WHODrug
- Data entry and reporting in ARISg™, Argus Safety™, Clintrace™ and other proprietary systems
- Electronic submissions to EMEA and FDA
- Expertise in system and MedDRA upgrades and data migration
Safety Response Center
- Staffed with health care professionals
- Equipped with unique browser-based applications to track and respond to
medical inquiries, product complaints and adverse events
- Available 24 hours a day, 7 days a week
- Supports all global languages
Highly scrutinized by independent audits in 2007
- Passed 7 of 7 audits by current clients and their designated consultants
- Awarded 10 of 10 contracts that were contingent upon successful inspections
- Supported 9 clients with pharmacovigilance operations inspected by FDA, EMEA or MHRA, and all had positive outcomes
- Completed a direct audit by FDA in 2006 with a very positive outcome
Focused on quality and client satisfaction
- 100% of cases are data verified and checked for case content accuracy through a 2-step quality review process
- Phone calls are monitored for quality and training
- Metrics for service-level agreements are developed and measured for every client
- Account Executive is assigned to every client to manage all activities
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