News & Articles
Latest news and informative articlesNews
Waving Farewell to 2020 and Looking Forward to 2021
Scott McGregor reflects on 2020 and looks forward to 2021
Clinical Trials News and Regulations
Our latest Industry Update finishes the year focusing on COVID-19 & BREXIT
MHRA Post-Transition Period Information
All the information you need on the BREXIT transition direct from our Regulatory Team
Biomedical Concepts: The Time is Now
Biomedical Concepts are at the centre of the A3 Suite. Find out more …
MHRA Submissions – The UK submissions portal from 01 January 2021
Find out about the MHRA Submissions Portal by talking to our team.
Virtually Standing: The CDISC and PHUSE Challenge
Dave Iberson-Hurst and AJ de Montjoie focus on the Virtual Event experience …
Autumn Events with S-cubed & A3
Meet us at many events this autumn
Challenging the Process: A3 Terminology MDR
Adam de Neergaard talks terminology
Clinical Trials News from around the Globe
All the latest regulatory updates compiled for you by S-cubed.
Lies, Damned Lies & Statistics
Elizabeth Merrall fights for statistical truth!
Covidgraph: One Nerd’s Response to the Pandemic
Kirsten Langedorf gets nerdy about graphs!
EMA Publishes Updated Guidance on Nitrosamines Impurities
Latest news from EMA regarding nitrosamines
Down the SDTM Rabbit Hole – Scratching an Itch
Johannes Ulander finds himself falling down an SDTM rabbit hole…
Marketing Authorisation Holder GMP-related Responsibilities
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
Clinical Development Practices & Regulations
Our latest Industry Update for Q2 covers the latest regulatory information around COVID-19 and much more.
A3ccelerate, Social Distancing, and Toblerone
Dave Iberson-Hurst reflects on a highly successful TransCelerate Hackathon.
Technology and the Life Sciences: The Trouble with IT
How can we drive change in Pharma? It starts with the data.
Supporting Clients using Full Service CROs
Our Biometrics team discuss how S-cubed can help companies that outsource Biometrics activities to a full-service CRO.
COVID-19: European Medicines Agency Updates
Latest updates from EMA in response to the COVID-19 pandemic.
CDISC Interchange 2020 Goes Virtual and We’ll Be There!
The CDISC Interchange has gone virtual and S-cubed will be there in 3 streams.
Nitrosamine Risk Evaluation for Marketing Authorisation Holders
The deadline for Nitrosamine Risk Evaluation is looming. Are you ready?
Articles
Biomedical Concepts: The Time is Now
Biomedical Concepts are at the centre of the A3 Suite. Find out more …
Marketing Authorisation Holder GMP-related Responsibilities
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
An overview of PRIME, Breakthrough Therapy & Fast Track procedures
This article provides an overview of PRIME, Breakthrough Therapy and Fast Track regulatory procedures intended to optimise the development of medicines that target an unmet medical need.
Optimising the path to commercialisation; Who can help and when?
Regulatory Affairs Expert Tony Mitchell co-authors a case study for a new IBS Drug This is case study for a joint project S-cubed worked on for a new drug for IBS – PharmaVentures was the lead company and they were providing market valuation expertise, Apex Healthcare...
INDUSTRY INSIGHTS
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The industry insights features the latest news and developments from the pharmaceutical industry.
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Featured in this issue of Industry Insights:
- COVID – 19 Guidance
- BREXIT
- Regulations and Guidance
- Trial Management
If you want to contribute or share something that you’d like to be listed in the next issue, please feel free to contact us.