Biostatistics

We Provide state of the art biostatistics services, ensuring full support to our clients throughout all phases of clinical development. Our expert biostatisticians apply their knowledge and expertise to support in the study design, data analysis, and reporting of results, while using the latest statistical techniques and software. Our Team Provides high quality deliverables while securing full conformity to study timelines and milestones.

Biostatistics Services include

  • We generate sample size calculations for clinical trials for any phase of the drug or device development cycle.

  • In order to produce treatment groups and help preventing bias in clinical trials, our team produces randomization schedules based on the protocol design utilizing SAS Software.

  • Our team prepares a complete SAP including detailed description of all patient populations and statistical analyses to be carried out on the data collected during clinical trial.

  • Prior to delivering statistical tables, listings and/or figures to clients, all statistical programs are subject to validation through independent review of programming code by a different statistical programmer or statistician from the one who generated the original programs. All statistical tables, listings and graphs are generated using the CDISC standards for generating SDTM and ADaM datasets.

  • Statistical report is produced in conjunction with the preparation of the final clinical study report. The statistical report provides detailed description of the statistical analyses’ findings and confirms that analysis was conducted per the SAP and also includes any deviation from SAP or any additional unplanned analyses conducted.