News & Articles
Latest news and informative articlesNews
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.
Pharmaceutical Industry Events this Autumn
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
Global Harmonisation of Clinical Trials is the latest focus for our quarterly roundup of the regulatory landscape with news from EMA, FDA and ICH
Protocol writing is changing – Estimands (ICH E9(R1))
This month Darren Jolliffe, explains how S-cubed can assist you in applying the forthcoming regulatory guidance ICH E9(R1)
CDISC 360 Project and the A3 Suite
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.
CDISC, PhUSE, DADM – Events Update
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 Machine Learning – Cause for concern or excitement?
Statistics and the impact of machine learning get Elizabeth Merrall thinking and considering the future.
Latest News in Clinical Development Practices and Regulations
Our latest Industry Insights focuses on Brexit and news from the regulators around the globe.
10 Years of S-cubed at CDISC: The Interchange 2019
As we head to the CDISC Interchange this week, make sure you see our presentations and meet our team at Stand 11.
Articles
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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- Clinical Trial Regulation: EU No 536/2014
- ICH E6(R2)
- Brexit
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