By using smart designs, sponsors can save time and money while optimizing the knowledge accrued during the development of their products.
“Traditional” study designs and statistical methodology do not allow changing the main features of a study protocol once the study has been initiated. The use of interim analyses, and in particularly the development of group sequential analysis methods introduces some flexibility in the study designs by allowing interruption of treatment arms (or the whole study) after early demonstration of efficacy (or evidence of futility) at a planned interim analysis.
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).