Biostatistics and Analytics

Biostatistics plays a crucial role in clinical trials and in the drug development process. Biostatistics are involved in every step of clinical research including trial design, protocol development, data management and monitoring, data analysis and clinical trial reporting.

Orcigenix provides complete statistical services across a comprehensive portfolio of therapeutic areas – from study design consulting to full service clinical trial biostatistics support for Phase I to Phase IV clinical trials. We have the best team of statisticians who can provide advice throughout the entire compound development process, offering far more than a service just to be dipped in and out of whenever numbers crop up.

Our Services include

• Statistical Analysis Plan (SAP) - study endpoints, sample size calculation, interim analysis planning and the hypothesis and testing procedures.
• Utilization of varied and complex statistical techniques to support any trial.
• Expertise in Adaptive and Bayesian trial designs to re-estimate sample size or change study designs or hypothesis in accordance with the trial progression.
• Production of Integrated Summaries for Safety and Efficacy (ISS/E).
• DSMB advice and support, or critique of existing data set/studies.
• Statistical review input to ensure the results of clinical trials are correctly interpreted and communicated.
• Generating Clinical Study Report (CSR).
• CDISC expertise (use and thorough understanding of CDISC standards).