Biostatistics

Our panel of Biostatistics services includes:

  • Sample size and power calculations
  • Statistical protocol development
  • Randomization lists and code-breaking envelopes
  • Statistical analysis plans and reports
  • Programming and production of tables, listings, and graphs
  • Independent data analysis center to perform interim blinded analysis, support for DSMB and IDMC
  • Data pooling and integrated analysis (ISS, ISE)
  • Statistical consulting for submission to regulatory authorities (FDA)
  • Efficacy, immunogenicity, safety, and reactogenicity analyses
  • Conversion of legacy data to CDISC-ADaM and CDISC-SDTM standards
  • Development, verification, and validation of standard macros
  • Data de-anonymization

Consultancy Support & Staffing Solutions

Consultancy Support & Staffing Solutions

We provide outstanding and experienced short- to long-term on-site consultancy support for all types of clinical projects. Since 2004, 4Clinics Biostatistics has forged strong relationships with several leading pharmaceutical and biotech companies in drug, biologics, and vaccine development.

The 4Clinics Biostatistics team is experienced in initiating and supporting clinical trials through their conclusion. We provide expertise in late clinical phases (phase II/III and IV), including interim analysis for drug, vaccine, and epidemiological studies.

Our mission is to support 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 for CDISC-related projects.

The Biostatistics team at 4Clinics is knowledgeable and experienced. 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 and undergo regular intensive training to maintain their skills and knowledge of statistics.