News & Articles
Latest news and informative articlesNews
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
Darren Jolliffe discusses 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?
Clinical Trial Regulation, ICH E6(R2) & Brexit
Our first Industry Update of 2020 focuses on Clinical Trial Regulation, Brexit and the latest from FDA & EMA.
Clinical Monitoring – What We’ve Learned
Clinical monitoring shouldn’t be difficult and in the hands of our expert team, you’ll be set up in no time.
CDISC Terminology – Gain control using the A3 Community MDR
20 years of working with CDISC led to the birth of the A3 Community MDR. Read the story here.
MAH Nitrosamine Risk Evaluation update – 1 month to go
With just one month to go, have you completed your risk evaluations? Make sure you are ready!
LOINC Codes and CDISC Lab Data – A Practical View
What do you know about LOINC? Niels Both gives a personal view of what you need to know.
Simultaneous National Scientific Advice (SNSA)
The EU Pilot for 2 Member States to gain simultaneous national scientific advice is launched on 1st February. Find out more here.
Nitrosamine MAH Risk Assessment – Two Months to Go
Two Months to Go – Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities
Finalised ICH E9(R1) Estimands and Sensitivity Analysis Guidance
Darren Jolliffe revisits Estimands after it’s adoption in November. Find out how we can help.
Growth, a new office and successful software!
It’s been a fantastic year for S-cubed. Read the reviews from our three managing directors in the UK and Denmark.
Nitrosamines, TOPRA, Drug Development News
Nitrosamines, TOPRA, & Drug Development News are the focus for our Q4 Industry Insights
A3 Community MDR Now Launched
S-cubed is pleased to announce the launch of the A3 Community MDR provided free for the benefit of the CDISC user community.
Using Real World Data to Enhance Pharmaceutical Development
Elizabeth Merrall discusses the case for using real world data (RWD) in clinical research.
Articles
Marketing Authorisation Holder GMP-related Responsibilities
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
Qlik: S-cubed Commenting Extension
Bohua Li introduces an S-cubed extension for adding user comments in a Qlik Sense application, along with a guide for users to implement the extension themselves.
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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Featured in this issue of Industry Insights:
- COVID – 19 Guidance Updates
- Clinical Trial Regulation (CTR) EU No 536/2014
- Brexit
- Publishing Trial Results
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.