Drug Safety Navigator
Drug Safety Navigator, LLC (DSN) is a unique company dedicated to medical product safety and pharmacovigilance. DSN works with safety and pharmacovigilance specialists from around the world whose expertise and experience is in line with the specific needs of our client base – small to mid-sized companies.
|Drug Safety Navigator|
|Type||Public / Private|
DSN was founded in 2012 based on the guiding principle that “Patient Safety is our True North.” After years of experience with sponsor companies and contract service providers, DSN founders built the company by identifying and managing the most suitable experts for each projects and/or issues. Our experience with “Best of Breed” model proves it works well for those clients with complex and challenging situations. These usually require more depth and flexibility than most companies can provide with limited in-house resources.
Now with the recent acquisition of Five Oaks Pharm, LLC, DSN offers even more safety support. DSN can act as your full virtual drug safety department or provide supplemental support for existing safety departments. Our services now range from individual case handling to more complex issues such as integrated analyses of safety and benefit-risk assessments.
Oracle Argus Safety Database
Some key features of Argus are:
- 21 CFR Part 11 fully compliant and validated system with 24/7 support
- Full reporting capabilities, including individual case and aggregate reports
- Supports E2B file exporting and importing
- Compliance Reports and Frequency Reports for Signaling Detection
- ISO 9001 and ISO 27001-certified.
- Adverse Event Data Collection & Management
- Regulatory Inspection Preparation
- Safety Reporting
- Safety Signal Detection
- Other PV Services
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