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Whether it’s creating and maintaining an electronic database or making expert benefit-risk assessments, ISS, Inc. delivers a full range of drug safety, medical product safety, pharmacovigilance and risk management services. These services include:
- Complete Serious Adverse Event (SAE) Management and Handling
- Expedited Reports (MedWatch/CIOMS forms)
- Creation and Maintenance of a Validated (21 CFR Part 11) E2B-compliant SAE Electronic Database
- CIOMS Line Listings
- Benefit-Risk Assessments
- Design of Risk Management Plans
- Registries
- Phase IV Studies
- Large Simple Safety Studies
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