News & Articles
Latest news and informative articlesNews
Protocol writing is changing – Estimands (ICH E9(R1))
This month Darren Jolliffe, Director of S-cubed Biometrics Ltd, 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.
S-cubed Announces A3 Informatics Merger and New Partners
S-cubed is pleased to announce that S-cubed and A3 Informatics have merged to bring the A3 Suite of tools inside the S-cubed brand.
Celebrating 10 Years of Regulatory Affairs and Quality Assurance
Regulatory Affairs and Quality Assurance – S-cubed Ltd are 10 years old. Find out about how our team came together and continue to grow.
Data Silos, Demos, Discussions at PhUSE
The latest papers and presentations from PhUSE US Connect in Baltimore and our future events, including CDISC.
Brexit, EMA, FDA & Global Regulatory News
Our first Industry Insights of 2019 focuses on the latest regulatory developments and Brexit.
PhUSE Keynote – A Cautionary Tale
A fascinating talk by the Keynote Speaker, Dr Ahadpour from the FDA on the opioid addiction crisis in the USA.
Regulatory Affairs & Quality Assurance: Copenhagen
Jakob Sandersen reports on the exciting developments at Pharmaceutical Services ApS over the last 15 months.
PhUSE US Connect & CDISC
Learn all about our presentations at PhUSE US Connect in Baltimore and at the CDISC Interchange in Amsterdam
SME Day at EMA – Part 3
The final report from Larissa Gould on the SME Day at EMA focuses on the Committee for Advanced Therapies, new Medical Devices Regulation and a Brexit update.
Qlik Specialization Status Awarded to S-cubed
Our Qlik Team are proud to announce that they have been awarded Pharmaceutical and Biotech Specialization status.
SME Day at the EMA – Part Two
Part Two of the report from the SME Day at the EMA focuses on Marketing Authorisations and more.
SME Day at the EMA – Part One
Larissa Gould reports from the EMA in Canary Wharf on the latest developments.
Brexit Update, Clinical Trial Data Sharing, & more
Our latest industry update covers news about Brexit, from FDA, EMA and more.
Qlik Team on Tour – Are you part of the Data Revolution?
Our Qlik Team are on Tour in Stockholm. Be part of the Data Revolution and join them there!
EMA, PhUSE, Bioforward and the latest Staff Update
Our staff and events teams are working hard, as we head towards the end of the year.
PhUSE Connect and future CDISC Training at S-cubed
We look forward to seeing you at PhUSE or our CDISC Public training in November.
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.
Regulatory Affairs: 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...
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