To deliver high-quality clinical research, we know that good data needs good reporting. Our biostatistics team helps achieve this by being involved during the deployment of the electronic data capture (EDC) system. The biostatistics team supports the data managers in the design of case report forms (CRFs) and electronic case report forms (eCRFs), and ensures dataset standard compliance (CDASH and CDISC). The biostatistics team will also provide support during data-cleaning activities to confirm that the final datasets are perfectly aligned with our reporting processes and meet all statistic needs.  Below are just a few of the statistical and study biometrics services that our team will deliver to help maximize the efficiency of your clinical trial.

Biostatistics Services

  • Sample size and power calculations
  • Study randomization schemes
  • Fixed statistical design and adaptive statistical design
  • Bayesian statistical design and analysis
  • Writing statistical sections of protocol
  • Tables, listings and figure (TLF) production
  • CDISC SDTM and ADaM dataset production
  • Statistical analysis and reporting
  • Writing statistical sections of the clinical study report (CSR)
  • Data Safety Monitoring Board (DSMB) support
  • Development Safety Update Report (DSUR) support
  • Integrated summaries of safety and efficacy
  • Pharmacokinetic (PK) and pharmacodynamics (PD) analysis

full-service CRO biostatistics