Insights

From January 31st, 2023, it will be mandatory to use Clinical Trials Information System (CTIS) for the submission of clinical trial applications (CTAs) and for documents related to the maintenance of the clinical trial authorisation for clinical trials in Europe. In this insight, Principal Consultant Lena Brahe briefly describes the CTIS, and then focuses on the Investigator’s Brochure and explains the implications sponsors should be aware of following the requirement for public disclosure of information submitted to CTIS.

Martin Willer provides a guide to choosing the right expression system for heterologous protein production. Every expression system comes with a unique profile of strengths and weaknesses that should be considered, including both qualitative and quantitative parameters. This includes the factors you should consider and why it is important to plan your documentation process from the very start.

The EU’s new Clinical Trials Regulation (CTR) is now live! This Insight briefly describes the purpose of the new regulation and shares 5 important considerations for clinical trial sponors.

Testing and validation are a central component of ensuring the security and continuity of computerized systems. For this reason, automation of testing efforts is an important aspect of an overall automation strategy. This Insight outlines the benefits of test automation and discusses how Selenium can be used to automate processes, like regression tests in Veeva, which have traditionally been done manually.

DevOps has become a bit of a buzzword, its use in practice is often too vague. To demystify the topic, this Insight examines DevOps from a technical perspective. By viewing the concept through the lens of Cloud Computing and Infrastructure as Code (IaC), a fuzzy DevOps concept becomes much more clear.

Ensuring compliance with the European Pharmacopeia (Ph. Eur.) is a cornerstone of European GMP compliance. This Insight highlights the importance of monitor coming changes in the pharmacopeias, and highlights the latest revised general monograph 2.2.46 Chromatographic Separation Techniques.

Pharma IT Consultant Sara Hamilton discusses the important highlights of two reports published in late 2021 which are relevant and informative for improving compliance in pharmacovigilance.

Stig Ragborg highlights why you may want to take a step back to take the right leap forward in your Digitalization for Labs of the Future (LoTF) process. Keep reading to learn more about what you should consider during this process and why you shouldn’t overlook the basics.

Pharma IT Partner, Jakob Juul Rasmussen, highlights the client case of Ascelia Pharma which recently went live on the Pharma IT Cloud EDMS+QMS platform – a secure, and fully GxP-compliant EDMS+QMS solution.

Senior Consultant, Martin Blædel, highlights the latest changes in the guidance on quality of water for pharmaceutical use, as well as their implications for pharmaceutical manufacturing.