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RTI-HS HomeOur ServicesDrug Safety and Pharmacovigilance › Pharmacovigilance Services

Pharmacovigilance Services

We provide a comprehensive plan to help you manage your pre- and post-marketed product safety program. Our services include:

SAE/AE Handling
  • Adverse event (AE) and serious adverse event (SAE) data entry and logging
  • Current treatment utilization patterns
  • Disease burden and prevalence
Data Management
  • AE and SAE logging, tracking, coding
  • and case processing
  • MedDRA and WHO-DD coding
Medical Analysis
  • AE and SAE evaluations
  • SAE narrative writing
  • Physician medical review and signal detection
  • Literature reviews and summaries
Regulatory Reporting
  • Generation of MedWatch 3500A/CIOMS I forms
  • Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
  • Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports

Electronic Adverse Event Reporting
We have the flexibility to use our clients’ proprietary or licensed electronic reporting systems, or we can use Argus Safety™, a leading technology for SAE and AE case management and reporting. Our Argus Safety license allows us to provide a fully validated 21 CFR Part 11 compliant system that can be customized to meet your needs.

End-User Focused Approach
We follow the FDA's Good Pharmacovigilance Practices and EMEA's European Directive 2001/20/EC guidelines and focus our work-products on the end-user perspective.

 


 
SENIOR LEADERSHIP

 
Maria Vazquez-Gragg, MD, MPM
Global Head, Safety and Pharmacovigilance


For a full list of scientific staff bios, click here.

 
DOWNLOADS

  Fact Sheets
- Pharmacovigilance
- Medical Monitoring
- Medical Consulting and
Writing
- Pharmacoepidemiology
- Therapeutic Risk Management

Other
FDA's Guidance for Industry:
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

EMEA's Guidance
- Directive 2001/20/EC (Clinical Trial Directive of 4 April 2001)
- Pharmacovigilance for Medicinal Products for
Human Use


CONTACT US
To learn more about our research and consulting services, please call us at:
US: +1.800.262.3011
Spain: +34.93.241.7766
UK: +44(0)161.232.3400
Or email one of our experts directly.
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