P95

P95 is a Belgian based company offering solutions in Pharmacovigilance and Epidemiology. P95 provides support for the design, conduct, and analysis of epidemiological studies as well as for the identification and analysis of patient databases. P95 also assists with all aspects of the drug/vaccine safety process, including the development of risk management strategies and benefit-risk assessments.

 

• Services:

Pharmacovigilance:
• QPPV services
• Vaccine/Drug safety project management
• Individual Adverse Event management
• Production of Periodic Safety Reports
• Implementation of signal detection
• Risk management
• Process development or Maintenance
• Training

Epidemiology:
• Epidemiological study design, planning, coordination and management
• Identification of investigators
• Development and review of protocols
• Collection and monitoring of data
• Monitoring of study sites
• Report writing
• Identification, design and analysis of large claims data sources or electronic records
• Development of registries and monitoring systems for pharmacovigilance and REMS programs
• International prevalence and incidence estimates, including those for rare diseases
• Literature reviews and meta-analysis
• Publication writing
• Writing of grant applications
• Process development or Maintenance

Pharmaco-Epidemiology:
• Benefit – Risk assessment
• Signal Detection and evaluation activities
• Aggregate case reviews
• Observed to expected analyses
• Risk Management activities

Biostatistics:
• Statistical analyses (e.g. interim and final study analyses)
• Data mining
• Disproportionality analyses
• Meta-analyses

P-95

P95
Koning Leopold III laan 1, 3001 Heverlee, BELGIUM
+32 474 53 48 68
www.p-95.com