Biostatistics and Statistical Programming

Biostatistical Services have always been a key component of Guires CRO services. Our experienced biostatistics team extends help at all phases of clinical trials from pre-clinical analysis to clinical and post-marketing support to pharma, medical device, food and nutraceutical-based trials. Based on ourclient’s needs, we customize our solution and present the results in clear and precise manner. At Guires, we provide support on the following clinical biostatistics services

• Data Integration and standardisation: We ensure that data are formatted according to the latest data standards (CDISC Compliance and CDISC mapping expertise) and comply with the FDA Data Standards Catalogue
• Pre-clinical studies – Provide advice on the study design and objective.
• Input on the protocol that includes clinical study design, sample and power calculation, and many more
• Randomization
• Preparation of Statistical Analysis Plan (SAP) delivered as per the requirement
• Creation of Mock Shells
• Final TLFs
• Output delivered using standard macros within the SAR programming system
• PK/PD analysis, production of statistical report / clinical study reports
• Perform blind data review checks
• Interim analysis
• Meta-analysis
• Adaptive and Bayesian designs
• Independent data monitoring committee