P95

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http://www.p-95.com
P95 Excellence in pharmacovigilance and Epidemiology
Type Private
Industry Pharmacovigilance, Pharmaco-Epidemiology, Epidemiology, and Biostatistics
Founded 2011
Headquarters Heverlee
Number of employees 11-50


About us

Innovative

We look for new solutions for old problems. This can be by using a new source of information, a new biostatistical way to analyse a dataset, a new interpretation of an old guideline etc.

Sense of urgency

No time to waste. We know and appreciate the urgency of many of the requests we get. Your timelines become our objective.

Passionate

We care about public health and how we can contribute to it.

We are proud of what we deliver to our clients.

Services

Pharmacovigilance

  • 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 
  • Expert advice

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 
  • Statistical analyses (e.g. interim and final analyses) 
  • 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 
  • Training 
  • Expert advice

Pharmaco-Epidemiology

  • Benefit - Risk assessment 
  • Signal Detection and evaluation activities 
  • Aggregate case reviews 
  • Disproportionality analyses 
  • Observed to expected analyses 
  • Risk Management activities 
  • Meta-analyses

Biostatistics

  • Data mining
  • Data analysis
  • Statistical Analysis Plan
  • Power and sample size estimation

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