P95 is a SME, founded in 2011 as a consulting business in epidemiology and pharmacovigilance.

P95 rapidly expanded its customer base, as well as the scope of services, moving from mostly consulting to study support, analytical support and writing support,. In 2015, P95 obtained a grant from VLAIO, the Flemish Agency for Research and Innovation to set up a Database Analytics Center (DAC). In parallel, P95 also expanded its services to the public sector with contracts from the WHO, the European Commission, the European Centers for Disease Control and the Belgian Ministry of Health. As a private research organisation, P95 enjoys a privileged position at the crossroads of academia, industry and government institutions.

P95 is also involved in two different projects under the Innovative Medicine Initiative: ADVANCE (Accelerated development of vaccine benefit-risk collaboration in Europe), which P95 coordinates; and DRIVE (Development of Robust and Innovative Vaccine Effectiveness), where P95 is leading WP4 on methods and analytical tools and guidelines. The area within which P95 operates is largely focused on but not limited to infectious diseases and vaccines. P95 has also been involved in projects related to cancer, women’s health, allergy and others.

Real World Data Analyses

A rather vague term, Real World Data for us means databases that contain sufficiently detailed medical information on a sufficiently large population to be used for generating evidence on the need and impact of medical interventions. These can be electronic medical records spanning a large number of patients, hospitals or GP practices, health insurance records (billing information), surveillance databases, laboratory databases, registries, prescription databases and more.

To enable clients to make optimal use of this increasingly rich and extensive source of medical data, we offer the following services:

  • Feasibility assessment
  • Single database analyses
  • Multi-database analyses
  • Analytical services
  • QC support
  • Coding support

Some examples of projects in this area:

  • Modeling the burden of infectious acute gastro-enteritis in England
  • The role of Hepatitis B infection in NAFLD among diabetics
  • The seasonality of GBS in England
  • Effectiveness of Zoster vaccination and reasons for vaccine failure
  • Effectiveness and impact of rotavirus vaccination

Pharmacovigilance

While a company’s goal is to move a drug through all phases of development in a timely and cost-efficient manner, the obligation to protect public safety remains paramount. Adequate monitoring and assessment of drug/vaccine safety during development and product lifecycle is a vital concern of both industry and regulatory authorities.

These include the following activities, which are all supported by P95:

  • Benefit-risk assessment
  • Individual Adverse Event management
  • Aggregate case reviews
  • Periodic Safety Reports
  • Signal detection and evaluation
  • Risk management plans and risk evaluation and mitigation strategy
  • Process development
  • QPPV services
  • Training
  • DSMB or IDMC support

Some examples of projects in this area:

  • A quantitative benefit risk assessment of a vaccine
  • Full development and management of a risk management plan for a new vaccine in clinical development
  • Protocol development and feasibility assessment of maternal and neonatal outcomes following maternal immunisation
  • Rapid assessment of reactogenicity of a seasonal influenza vaccine

Epidemiology

P95 provides comprehensive services to address your evidence needs. From burden of disease to effectiveness and safety studies, we are able to provide epidemiological and statistical expertise tailored to your needs.

  • Observational studies
  • Surveillance systems
  • Advanced statistical modelling
  • Systematic, focused and rapid literature reviews
  • Meta-analysis
  • Evidence gap analysis
  • Health economics: cost-of-illness analysis and modelling
  • Evidence mapping

Some examples of projects in this area:

  • Systematic literature review and meta-analysis of vaccine effectiveness and impact following vaccine introduction in national immunisation programmes
  • Systematic literature review of a vaccine’s effectiveness in the diabetic sub-population
  • A EU-wide study of the burden of Norovirus hospitalisations
  • Mapping and analysis of evidence gaps in the burden of disease of a vaccine preventable disease
  • Observational field study on the burden of gastroenteritis in children across 4 countries, including cost-of illness analysis
  • Observational field study on the burden of travellers diarrhoea in adults, including cost-of-illness analysis

Data analytics

We provide analytical services, both in support of our Pharmacovigilance and Epidemiology services, but also as a stand alone service.

  • Database analytics
  • Real-world data identification
  • Algorithm development
  • Data visualization tools
  • Data mining
  • Process and methods development
  • Quality control
  • Small cell risk analysis

Some examples of projects in this area

  • Re-analysis of study data
  • Small cell risk analyses for a chronic disease registry prior to its release for research purposes
  • Development of an interactive dashboard to represent at the European level data for disease incidence and prevalence per country, data source, age group, time period and disease type

Writing services

We provide writing services to support other services, and also as a stand alone service.

  • Secretariat services
  • Conference/meeting proceedings and reporting
  • Grant writing
  • Study reports
  • Manuscripts
  • Conference abstracts

Some examples of projects in this area

  • Scientific secretariat for the Scientific Panel for Health, European Commission
  • Meeting reports for the Human Papillomavirus Prevention & Control Board
  • Secondary analysis manuscript on Herpes Zoster vaccine

Training

We can provide training in the following areas:

  • Infectious disease epidemiology and methods
  • Pharmacovigilance
  • Statistical methods

Some examples of projects in this area:

  • Training in infectious disease epidemiology for medical writers
  • Training in PSUR writing, safety signal detection and evaluation for the pharma industry