Establishing a robust approach that integrates an understanding of statistics, genetics and clinical outcomes in the design of your PGx studies will improve efficiency of your pipeline, reduce risk and cost and enable you to obtain meaningful results that address your scientific and business objectives.

BSSI offers high-level guidance on developing protocols and SAPs, with emphasis on the unique objectives of your study. Careful planning will enable you to save time and cost now and ensure the current study provides valuable information in the context of your future directions.

We understand that you may be faced with seemingly endless questions:

• What are your primary and secondary hypotheses?
• What is required for you to identify, develop and validate a clinical biomarker?
• How will your definition of phenotype impact the search for genetic association?
• How will the complexity of your clinical trial and study population impact the analysis?
• How will you interpret the vast amount of information obtained in a genome-wide study?