Pharma IT Insights

Pharma IT Insights

Pharma IT provides insights on IT Applications, Medical Devices, Drug Development, and more. All of our insights are based on the latest knowledge within Pharma, Biotech, and IT - and all insights are written by our consultants.

Featured Insight

The Pharma IT Academy recently hosted Sion Wyn for an exclusive event highlighting the new GAMP5 Second Edition. In this Insight, we recap the event and provide 3 Key Takeaways concerning Critical Thinking, Agile Methodology, and the Case for Quality.

Latest Insights

Omnichannel Marketing in Pharma with Martin Rother Breyen

Omnichannel Marketing is a key trend within the commercial pharma space. For this Insight, we sat down with Director of Commercial & Medical Systems, Martin Rother Breyen, to learn more about what it is, why it matters, and how to use it!

Increased disclosure of clinical trial documents following the EU Clinical Trials Regulation (CTR)

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.

Choosing the Right Expression System for Heterologous Protein Production

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.

An image of a clinical scientist in a lab setting, overlaid with the text "5 Considerations for Ensuring EU CTR Readiness"

Top 5 Considerations for Ensuring CTR Readiness

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.

Automated Testing of IT Systems in GxP environments with Selenium

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.

Importance of European Pharmacopeia Monitoring for GMP Compliance

Importance of European Pharmacopeia Monitoring for Lab GMP Compliance

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.

Pharmacovigilance During COVID-19

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.

The Latest Update on WFI and Sub-Visible Particles

The regulatory environment surrounding the pharmaceutical industry is constantly evolving. In this insight, Pharma IT’s Director of Chemistry, Manufacturing, and Control (CMC), Torben Elhauge, highlights two significant Pharmaeuropa developments you should be aware of.

Validation of IT Systems Used in Clinical Trials

Regarding the outsourcing of clinical trials, the relationship between sponsors and their Contract/Clinical Research Organisations (CROs) is a complex one. This insight, provides a useful tool that can be used as a guide for sponsors looking to ensure a CRO’s IT Systems are compliant.

RPA in Pharma: Use-cases and Value

In this article, you will learn how RPA technology can be used in the Pharmaceutical and Biotech industries to drive value, optimize processes, and reduce risks. Furthermore, we will also provide examples of use-cases and show how you can get started with RPA quickly and efficiently.

Ensuring IT Compliance for Outsourced Clinical Trials

Since sponsors of clinical trials are ultimately responsible for the validation and provisioning of adequate documentation for computerized systems, thinking about computer system validation early on is a great way to ensure compliance and mitigate risk. In this Insight, we share 3 tips on optimal initial steps when conducting audits and approvals of CROs.

Interview on the Future of CSV with Jeppe Amossen

Computer System Validation (CSV) is currently undergoing rapid change – not least due to the advent of large-scale automation. We’ve had the chance to ask Senior Consultant Jeppe Resen Amossen about the future of CSV and Test Automation, including risks, benefits, and potentials.

Software as a Medical Device

Software is increasingly becoming the go-to method for diagnosing illnesses and monitoring health, creating challenges concerning new and updated legislation such as the EU MDR.


Are you looking for more expert knowledge on pharma and biotech?

Pharma IT provides highly experienced consultants for the Pharma, Biotech, and Medical Device Industries

Are you looking for more expert knowledge on pharma and biotech?

Pharma IT provides highly experienced consultants for the Pharma, Biotech, and Medical Device Industries