News & ArticlesLatest news and informative articles
The deadline for Nitrosamine Risk Evaluation is looming. Are you ready?
Our first Industry Update of 2020 focuses on Clinical Trial Regulation, Brexit and the latest from FDA & EMA.
Clinical monitoring shouldn’t be difficult and in the hands of our expert team, you’ll be set up in no time.
20 years of working with CDISC led to the birth of the A3 Community MDR. Read the story here.
With just one month to go, have you completed your risk evaluations? Make sure you are ready!
What do you know about LOINC? Niels Both gives a personal view of what you need to know.
The EU Pilot for 2 Member States to gain simultaneous national scientific advice is launched on 1st February. Find out more here.
Two Months to Go – Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities
Darren Jolliffe revisits Estimands after it’s adoption in November. Find out how we can help.
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 are the focus for our Q4 Industry Insights
S-cubed is pleased to announce the launch of the A3 Community MDR provided free for the benefit of the CDISC user community.
Elizabeth Merrall discusses the case for using real world data (RWD) in clinical research.
We’re at a number of events between now and the end of November, demonstrating our clinical data expertise. Get in touch if you’d like a meeting.
Global Harmonisation of Clinical Trials is the latest focus for our quarterly roundup of the regulatory landscape with news from EMA, FDA and ICH
This month Darren Jolliffe, explains how S-cubed can assist you in applying the forthcoming regulatory guidance ICH E9(R1)
The CDISC 360 Project is a major change in the way we access and use standards. Our A3 Suite is ready and tuned to the vision.
It’s been a busy few months for S-cubed. Find out where we’ve been and where we’re going to next.
Statistics and the impact of machine learning get Elizabeth Merrall thinking and considering the future.
Our latest Industry Insights focuses on Brexit and news from the regulators around the globe.
As we head to the CDISC Interchange this week, make sure you see our presentations and meet our team at Stand 11.
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.
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.
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...
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- Clinical Trial Regulation: EU No 536/2014
- ICH E6(R2)
- EMA & FDA Regulatory Updates