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 a variety of research activities including study support, analytical support and writing support.  As a private research organisation, P95 enjoys a privileged position at the crossroads of academia, industry and government institutions.

P95 was/is also involved in different projects under the Innovative Medicine Initiative having leading positions: ADVANCE (Accelerated development of vaccine benefit-risk collaboration in Europe), DRIVE (Development of Robust and Innovative Vaccine Effectiveness) and VITAL (Vaccines and infectious diseases in the ageing population).  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.


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
  • 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.

  • Systematic, focused and rapid literature reviews
  • Observational studies including protocol writing, identification of investigators, study monitoring, data collection, analyses and report writing
  • Surveillance systems
  • Advanced statistical modelling
  • All analytical requirements, including meta-analyses
  • Evidence gap analysis
  • Health economics: cost-of-illness analysis and modelling
  • Publication writing

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
  • A prospective study of the Quality of Life and economic burden of patients with sepsis in the United States
  • A EU-wide study of the burden of Norovirus hospitalisations
  • A protocol for a prospective study on the burden of Lassa fever in West Africa
  • Observational field study on the burden of gastroenteritis in children across 4 countries, including cost-of illness analysis
  • A prospective study on the burden of diarrhoea in adult travelers from Europe and the United States, including cost-of-illness analysis

IT Services

P95 has a broad expertise in IT services. We can aid with data capture and analysis platforms, data privacy measures and database services. P95 is also a certified SME for mapping a database to the OMOP Common Data Model. Next to these back-end services, we are also skilled in creating engaging front-ends, such as research dashboards and web applications using R and Python.

Some examples of projects in this area:

  • Development of a secure data-sharing platform for the IMI-DRIVE project
  • Development of interactive dashboards for post-marketing benefit-risk monitoring
  • 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
  • Successful certification by EHDEN for mapping databases to the OMOP Common Data Model


Real World Data Analyses and Analytics

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.

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

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

  • Real-world data identification
  • Feasibility assessment
  • Single and multi-database analyses
  • Analytical services
  • QC and coding support
  • Algorithm development
  • Data visualization tools
  • Data mining
  • Process and methods development
  • Quality control
  • Small cell risk analysis

Some examples of projects in this area

  • A database study on risk factors for a vaccine preventable invasive disease in Europe and North America
  • A database study on the prevalence of multidrug resistance in patients with a vaccine preventable invasive disease in North America
  • Modeling the burden of infectious acute gastro-enteritis in England
  • The role of Hepatitis B infection in NAFLD among diabetics In England
  • The seasonality of GBS in England
  • Effectiveness of Zoster vaccination and reasons for vaccine failure
  • 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 and Training

We provide writing services to support other services, and also as a stand alone service. We also provide training in epidemiology, pharmacovigilance and statistics.

  • Secretariat services
  • Conference/meeting proceedings and reporting
  • Writing of grants, reports, manuscripts and conference abstracts
  • Various trainings in infectious disease epidemiology, epidemiological methods, pharmacoviglance and statistics

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