FDA

Clinical Development Practices & Regulations

Clinical Development Practices & Regulations

Clinical Development Practices and Regulations are the main focus for our Q2 Industry Update. We also include important information about COVID-19, expertly compiled by Christina Hägglund, QA Manager, S-cubed Ltd. Read all the latest regulatory news here. You can download…
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…
LOINC Codes and CDISC Lab Data – A Practical View

LOINC Codes and CDISC Lab Data – A Practical View

CDISC have announced a public review of LOINC TO LB Mapping. Niels Both, our Partner and longtime CDISC Consultant, considers the practical implications for your work. LOINC coding provides a complex and sophisticated system to precisely identify lab parameters. For several…
Nitrosamines, TOPRA, Drug Development News

Nitrosamines, TOPRA, Drug Development News

Industry Insights for Q4 - 2019 Our latest regulatory updates for the final quarter of the year covers news from the FDA, EMA, important news about nitrosamines impurities, and much more. Christina Hägglund compiles the latest regulatory updates from around…
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…