Biostatistics
Since 2004, 4Clinics Biostatistics has built a strong relationship with several leading pharmaceutical companies in drug and vaccine development.
4Clinics biostatistics team is experienced in supporting clinical projects and can provide assistance beginning at the initiation of a clinical trial. In particular, we provide expertise in late clinical phases (phase II/III and IV), including interim analysis in both drug and vaccine development. We also have extensive experience in biostatistics for epidemiological studies.
Our mission is to help our clients in pharma and biotech launch and conduct clinical trials by providing statistical expertise, clinical data programming, statistical analysis and reporting. We also provide support in Biostatistics for preclinical activities.
We provide long and/or short-term consultancy support on client's site.
Biostatistics team
At 4Clinics, we have a knowledgeable and experienced Biostatistics team. All statisticians have at least a Master's degree in statistics, and all have SAS programming skills. In addition, all receive training in GCP and ICH standards. Team members also receive ongoing intensive training to maintain their skills and knowledge of statistics.
Biostatistics services
- Sample size and power calculations
- Statistical protocol development
- Randomization lists and code-breaking envelopes
- Statistical analysis plan
- Programming and production of tables, listings, graphs
- Statistical report + appendices
- Statistical support to interim analysis and Data and Safety Monitoring Boards (DSMB, IDMC)
- Data pooling and integrated analyses (ISS, ISE)
- Statistical advices during submission to Regulatory Authorities (FDA)
- Immunogenicity and reactogenicity analysis
- Conversion of legacy data to the CDISC ADaM and SDTM standards
- Development, verification and validation of standard macros
- Data management
- Pharmacovigilance
- Biostatistics
- Medical & Scientific writing
- Regulatory Affairs
- Scientific communications
