FDA

LOINC Codes and CDISC Lab Data – A Practical View

LOINC Codes and CDISC Lab Data – A Practical View

Niels Both, our Partner and longtime CDISC Consultant, considers the practical implications of the FDA LOINC Requirements. *UPDATE* - This article was first published in 2020 FDA requires the submission of Logical Observation Identifiers Names and Codes (LOINC®) within clinical…
Regulations & Guidance: Clinical Trials

Regulations & Guidance: Clinical Trials

Regulations & Guidance feature in our Q1 Industry Update from Christina Hägglund, QA Manager S-cubed Ltd. You can download a pdf of this update here and sign up to receive our updates via email here. COVID-19 Guidance & Information Europe…
Clinical Trials News and Regulations

Clinical Trials News and Regulations

As we reach the end of 2020, we release our final Industry Update of the year, compiled by Christina Hägglund, QA Manager, S-cubed Ltd. This quarter, we cover the latest COVID-19 Guidance and BREXIT news. You can download a pdf…
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 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…