Integrating Total Solutions The practice of statistics is not a compliance exercise or a set of mathematical tools. It is a way of thinking and a set of methodologies that enable deeper understanding and proactive risk management. SynoloStats partners Tara Scherder and Katherine Giacoletti are recognized in the industry for their extensive involvement in the practical implementation of Quality by Design and the Lifecycle Approach to Process Validation in many small and large companies. They are very active in industry initiatives to provide guidance on best practices for the integration of risk management tools and statistics into pharmaceutical quality systems. They provide training, mentoring, and holistic quality system and specific project support to statisticians and non-statisticians on a wide range of topics. They are recognized for their focus on understanding the real business problem, thus providing truly value-added statistical advice, analyses, and strategy to meet the needs of the patient and the business.