On 20 November 2019, the final draft of the ICH Harmonised guideline E9(R1) “Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials” was adopted by the regulatory members of the ICH Assembly under Step 4 of the ICH process and consequently recommended for adoption to the regulatory bodies of ICH regions.
Brief History
The February 1998 ICH E9 “Note for Guidance on Statistical Principles for Clinical Trials” set out the principles of statistical methodology applied to clinical trials for marketing applications submitted in the ICH regions.
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).