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RTI-HS HomeOur ServicesDrug Safety and Pharmacovigilance › Pharmacovigilance Services

Pharmacovigilance Services

Good pharmacovigilance practices start with a good plan. We provide a bottoms-up approach to managing your pre- and post-marketed product safety program that will save you time and money and allow you to make good commercialization decisions about your products. These services include:

SAE/AE Handling
Call center support
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 understand that accurate reporting is vital to your safety programs. European regulators now require electronic submissions of individual case safety reports (ICSRs); and although currently voluntary in the US, it is anticipated that the FDA may require electronic reporting of SAE/AEs in the near future. This is why we have selected a leading safety database application to record and report SAE/AEs on behalf of our clients. It is a fully validated 21 CFR Part 11 compliant database that supports multiple products and studies. Furthermore, routine back-up and disaster recovery systems and procedures are in place, which is essential for safeguarding your data.

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, so practitioners and patients can fully realize the risk and benefits associated with a particular remedy. You can expect to work with a team of professionals who deliver quality results on-time and within budget.

 


 
SENIOR LEADERSHIP

  Wendy Painter, MD
VP, 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
Canada: +1.613.742.8225
Spain: +34.93.241.7766
UK: +44(0)161.232.3400

Or email one of our experts directly.

 

 

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