Robust research methods are fundamental for Clinical and Translational Research (CTR). Biostatistics and Research Design (BERD) and the Regulatory Knowledge and Support (RKS) provide innovative, evidencebased methods and processes that are key to UMass’ success in CTR. BERD meets the ever-increasing need for thoughtful study design and analysis in an era where the quantity of data available for CTR continues to explode and the seductiveness of easy-to-use and powerful analytic software may lead to scientific findings that are less than reproducible. Educational efforts to help clinical and translational researchers “know what they don’t know” and understand how to obtain support in these areas is paramount. We propose a service-oriented BERD that provides state-of-the-art statistical and study design consultation while also developing methodology and participating pro-actively in educational endeavors. Study teams need to be familiar with the regulations guiding CTR. RKS ensures translational research quality and integrity by providing a single integrated platform for proactive guidance and education, development of innovative tools, and continuous process improvement to facilitate regulatory compliance with all applicable rules and policies.