News & Articles
Latest news and informative articlesNews
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.
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?
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!
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
We revisit 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 we explain 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.
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INDUSTRY INSIGHTS
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Our Industry Insights features the latest news and developments from the pharmaceutical industry.
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Featured in this issue of Industry Insights:
- Updates to EU Pharma Legislation and ICH Guidelines
- Guidance Documents, Initiatives and Proposals
- AI and ML
- Medical Devices & IVDs
- Data Transparency and Data Protection
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.