FIRMPLACE

Biostatistics and Programming

Biostatistical activities are performed by quality assured Statisticians: each step of the process is validated by the quality control responsible biostatistician before being presented to the sponsor. Biostatistics can be offered on the stand-alone basis as well as with full services provided by the company:

·         Statistical consultation on study design (superiority, non-inferiority, equivalence trials);

·         Formulation of statistical section of study protocol;

·         Power analyses and sample size calculations;

·         Randomization (random allocation of study participants to tested groups);

·         Statistical Analysis Plan (SAP) development;

·         Statistical analysis including interim analysis of clinical data (using SAS Base and SAS/STAT);

·         Statistical modeling/exploratory analysis;

·         Statistical report and interpretation of clinical and statistical data;

·         Contribution to clinical study report writing.

 

Clinical trial development plan

·         Power/sample size estimation

·         Protocol development

·         Statistical analysis plan

·         Randomization schedule

·         Interim analysis

·         ISS/ISE/Annual report

·         Statistical modeling/Exploratory analysis

·         Statistical report

·         Clinical study report review


Statistical Programming

  • Development of analysis datasets (ADaM)
  • Support database edit checks, query creation, patient profiles and ad‐hoc report
  • Support of Data Monitoring Committee
  • Support for statistical method development, simulations, sample size calculations, exploratory analysis and research projects


 

Related Services

ConsultingProcess automation