CRS is able to provide full-service support through all phases of clinical development, with an emphasis on Early Phase expertise. To this end, CRS rely, when necessary, on a resilient and trustful collaboration with highly experienced external statisticians.
CRS successfully handles clinical trial projects of all sizes, ranging from small first-in-human (FIH) to larger proof-of-concept (POC) studies, e.g., it renders clinical development plans and/or individual study protocols, including study design, sample size determination, delineation of objectives and endpoints, as well as analysis strategies.
Our statisticians, who have extensive experience with clinical trials, can provide all relevant services encompassing:
• Statistics consulting
• Data integration and standardization by approved CDISC standards: Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standardized formats
• Complex study designs – Adaptive and Bayesian designs
• Study protocol support and writing of statistical analysis plans
• Regulatory submission support