ICH

Clinical Trials News from around the Globe

Clinical Trials News from around the Globe

With COVID-19 dominating clinical trials news, our latest industry update includes coverage of the key guidance documents issued by the regulators and much more. Compiled by Christina Hägglund, QA Manager, S-cubed Ltd. You can download the pdf of this update…
Clinical Trial Regulation, ICH E6(R2) & Brexit

Clinical Trial Regulation, ICH E6(R2) & Brexit

Clinical Trial Regulation, ICH E6(R2), Brexit and much more feature in our Q1 Industry Update, compiled by Christina Hägglund, QA Manager S-cubed Ltd. Read all the latest regulatory news here. You can download the pdf of this update here and…
Finalised ICH E9(R1) Estimands and Sensitivity Analysis Guidance

Finalised ICH E9(R1) Estimands and Sensitivity Analysis Guidance

Following on from our recent (August 2019) article, we provide an update on the finalised Estimands and Sensitivity analysis guidance. Full details of the ICH Harmonised Guideline can be downloaded here. The finalised addendum R1 to ICH E9 “Estimands and…
Global Harmonisation of Clinical Trials

Global Harmonisation of Clinical Trials

Industry Insights for Q3 - 2019 Our Q3 Industry Insights from Christina Hägglund provides an overview of everything you need to know about the latest regulatory updates from around the globe. Need advice or support? Then get in touch. Harmonising…
Finalised ICH E9(R1) Estimands and Sensitivity Analysis Guidance

Protocol writing is changing – Estimands (ICH E9(R1))

This month, our Biometrics team, explain how S-cubed can assist you in applying the forthcoming regulatory guidance ICH E9(R1) which will have a direct impact on how protocols are developed. The draft addendum R1 to ICH E9 “Estimands and Sensitivity…