P95, BV
Contract research organization focused on vaccines and infectious diseases. Provides end-to-end clinical trial services, epidemiology and real-world evidence (RWE), data management and biostatistics, safety/pharmacovigilance, and medical writing. Headquartered in Leuven, Belgium, with regional offices across multiple continents and experience delivering trials and epidemiological studies in low- and middle-income countries.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Consortium-based vaccine effectiveness and surveillance platform
Networked platform for multi-country vaccine effectiveness and burden studies using standardized epidemiological methods and hospital/study networks.
Challenge agent development guidance
Whitepaper covering selection, characterization, CMC documentation, quality control and storage considerations for challenge agents used in controlled human infection studies.
Consortium-based vaccine effectiveness and surveillance platform
Networked platform for multi-country vaccine effectiveness and burden studies using standardized epidemiological methods and hospital/study networks.
Challenge agent development guidance
Whitepaper covering selection, characterization, CMC documentation, quality control and storage considerations for challenge agents used in controlled human infection studies.
Services
End-to-end operational services for vaccine and infectious disease trials, from feasibility and site selection to monitoring, project management and trial close-out.
Design and conduct of non-interventional studies, surveillance, database studies and RWE analyses for vaccine effectiveness and disease burden estimation.
Protocol support, eCRF design, database setup and validation, statistical planning and analysis, CDISC conversion and regulatory reporting.
Safety program design, SAE management, 24/7 safety desk, expedited reporting and participation in safety boards.
Regulatory documents, clinical study reports, safety narratives, scientific publications and conference materials.
Local site selection, training, capability building and monitoring to enable high-quality trial conduct in resource-limited settings.
End-to-end operational services for vaccine and infectious disease trials, from feasibility and site selection to monitoring, project management and trial close-out.
Design and conduct of non-interventional studies, surveillance, database studies and RWE analyses for vaccine effectiveness and disease burden estimation.
Protocol support, eCRF design, database setup and validation, statistical planning and analysis, CDISC conversion and regulatory reporting.
Safety program design, SAE management, 24/7 safety desk, expedited reporting and participation in safety boards.
Regulatory documents, clinical study reports, safety narratives, scientific publications and conference materials.
Local site selection, training, capability building and monitoring to enable high-quality trial conduct in resource-limited settings.
Expertise Areas
- Vaccine clinical trial management (Phase I–IV)
- Epidemiology and real-world evidence generation
- Biostatistics and statistical analysis
- Data management and secure data environments
Key Technologies
- Electronic data capture (EDC)
- Electronic clinical outcome assessment (eCOA)
- GDPR-compliant secure data repositories and analysis environments
- CDISC data standards and data conversion
News & Updates
Webinar focused on running early-phase vaccine trials in Europe, including regulatory pathways, epidemiological inputs and adaptive designs. Recording available.
Article discussing challenges, infrastructure, regulatory complexity and approaches for conducting infectious disease trials in low-income countries.
Test-negative case–control study reporting vaccine effectiveness against hospitalization for the JN.1 variant across multiple European sites using a consortium surveillance platform.
Acquisition expanding data management and biostatistics capabilities.
Acquisition to strengthen clinical capabilities and market position in Europe.
Regional expansion of operations to strengthen vaccine research across Africa.
Webinar focused on running early-phase vaccine trials in Europe, including regulatory pathways, epidemiological inputs and adaptive designs. Recording available.
Article discussing challenges, infrastructure, regulatory complexity and approaches for conducting infectious disease trials in low-income countries.
Test-negative case–control study reporting vaccine effectiveness against hospitalization for the JN.1 variant across multiple European sites using a consortium surveillance platform.
Acquisition expanding data management and biostatistics capabilities.
Acquisition to strengthen clinical capabilities and market position in Europe.
Regional expansion of operations to strengthen vaccine research across Africa.