Services

P95 projects are largely focused on a broad range of infectious diseases and vaccines. However, P95 is also involved in projects related to cancer, women’s health, allergy and others, and is rapidly expanding its customer base and the scope of services.

Here is a list of some of the most requested services. Many other customised services can be provided upon request. P95 is happy to tailor services to your needs.

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Epidemiology

Pharmacovigilance

Benefit-risk assessment
Risk management plans and pharmacovigilance strategy
Post-Authorisation Safety Study (PASS) protocols and studies
Signal detection and evaluation
Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC) support
Individual adverse event assessment
Aggregate reports: Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs)

Data Analytics

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IT Services

Secure data storage and sharing
Interactive health data dashboards
Algorithm development
Quality control and coding support

Medical Writing

Scientific publications
Conference abstracts and presentations
Study reports
Meeting proceedings and reports

Training

Various trainings in epidemiology, pharmacovigilance and statistics

Global Reach

P95 is involved in projects at a global scale. P95 is currently supporting various vaccine manufacturers in their clinical development plans as well as their post-licensure plans for COVID-19. As such, P95 has a central role in the COVIDRIVE project – a public-private partnership to estimate brand-specific COVID-19 vaccine effectiveness in Europe. P95 also had leading positions in other projects under the Innovative Medicines Initiative (IMI): 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).

Here are some examples of our most recent contributions to vaccines in development or on the market

Flu & COVID-19 vaccine impact effectiveness studies
Client: European influenza and COVID-19 vaccine manufacturers
Duration: 5 years
Objective:
To monitor effectiveness of influenza and COVID-19 vaccines in Europe
Partners:
Fisabio (Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Spain) and THL (Finnish Institute for Health and Welfare)

Vaccine safety in pregnancy
Client: World Health Organisation
Duration: 3 years
Objective:
To assess the applicability of Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) case definitions for selected maternal and neonatal outcomes in low and middle income countries
Partners:
INternational CLinical Epidemiology Network (INCLEN)

Study of the impact of COVID-19 vaccination in Brazil
Client: The Bill and Melinda Gates Foundation (BMGF)
Duration: 6 months
Objective:
To measure the impact of a COVID-19 mass vaccination campaign

Escherichia coli disease epidemiology
Client: Vaccine manufacturer
Duration: >2 years
Objective:
To assess the burden of disease caused by invasive E. Coli infections
Partners:
Kaiser Permanente (United States not-for-profit health plan)

Lassa fever epidemiology
Client: Coalition for Epidemic Preparedness Innovations (CEPI)
Duration: 2 years
Objective:
To estimate the incidence of Lassa virus infection and Lassa fever disease in five West African countries to help designing future clinical trials
Partners:
CEPI, the Enable Lassa Research programme partners based in Guinea, Benin, Sierra Leone, Liberia and Nigeria, Epicentre (a not-for-profit association under Médecins sans Frontières), the Bernhard-Nocht-Institut für Tropenmedizin (BNITM), and the Margan Clinical Research Organisation (MMARCRO)