Biostatistics & CDM

It’s all about significance. Developing an appropriately powered clinical study, knowing where and when interim analyses should be performed, and experience in relational data mining are all important when it comes to interpreting clinical datasets. Project teams which incorporate proven biostatistical expertise into the design of a clinical study increase the odds of success, which could lead to expedited Agency review pathways. Our biostatisticians take the time to understand your product, the indication, the proposed clinical assessments, and approved standards of care. Let our experienced biostatisticians provide expertise in strategy, sample size, and data analysis, in order to yield reliable and significant results.

Comprehensive data management is the cornerstone of a successful clinical trial. Having the right person in place to assist with electronic case report form (eCRF) development and testing, proper review of data queries, implementation of data management plans, and relational analysis are just a few areas where experienced data managers enhance trial performance. By overseeing these activities at your CRO, assisting with the selection of appropriate database tools, reviewing vendor change orders, or assessing performance metrics, our data managers provide the expertise allowing for a closer relationship and better understanding of the status of your trial data.