CDISC

With over 15 years’ experience working with CDISC Standards, our subject matter experts lead the training and implementation of standards around the globe. They are at the forefront of the transformation of the standards working closely with CDISC on Biomedical Concepts.

Who do you want to talk to today?

Our Mission

Our team of highly qualified consultants will ensure that your CDISC data is submission ready. We work closely with you as part of your team to implement CDISC standards across the clinical data lifecycle. We deliver high quality data, first time every time.

Creating Value

We have advised, trained, and implemented CDIS standards in major pharmaceutical companies. With more than 20 successful FDA submissions, our consultants have experienced many of the challenges you may face. They will ensure that your data is high quality and accurate, saving time and unnecessary rework.

S-Cubed consultants have converted over 100 studies to CDISC standards

Been working with CDISC standards since 2004

We’ve supported more than 20 successful FDA submissions

100% accepted
by the FDA

Members of our CDISC team

We are CDISC Authorised Trainers in SDTM and ADaM.

Niels Both

Partner and Data Standardisation & Implementation Specialist

Niels Both has worked with clinical data handling and reporting since 1997, and has specialised in implementation of standard data models and standard reporting tools. Since 2004 Niels’ focus has been on the use of CDISC standards for FDA submissions, data warehousing and standardisation of dataflow processes from protocol to submission. Niels is an active member of the European CDISC Co-ordination Committee – E3C, and as part of this committee is working on several CDISC models, including SDTM, ADaM and CDASH. Niels joined S-cubed ApS in 2008.

Johannes Ulander

Principal Consultant and CDISC Subject Matter Expert

Johannes has been working with CDISC Data Standards for the last 15 years. He is a qualified CDISC SDTM trainer and delivers training for CDISC in and around Copenhagen. He is also a Linked Data expert and is one of a handful of global experts on linked data and graph databases. A regular presenter at PhUSE and CDISC events, Johannes is an expert in ensuring your company can leverage the CDISC standards in the most efficient way possibly, whilst ensuring your data is accurate and submission ready.

Kirsten Langendorf

Principal Consultant and CDISC Subject Matter Expert

Kirsten has worked with the CDISC standards for over 10 years, ranging from Protocol, CDASH, SDTM and ADaM. She has a vast range of experience working with and implementing CDISC standards and the associated change management processes. She is also a highly skilled project manager who can ensure that your CDISC implementation works with your current systems and any future installations. Kirsten is also part of the A3 Informatics team and is key to the development of future proofing your use of standards.

Mark Baillet

Managing Director & Consultant Statistician

Prior to starting S-cubed Biometrics Ltd in 2011, Mark was Vice President, Data Sciences at SRA Global Clinical Development, where he successfully formed, grew and led the global Biometrics department. Mark has over 23 years’ experience in conducting, managing and leading statistics, programming and data management functions within small and large pharmaceutical and biotech companies, including positions at Pfizer and British Biotech. Mark is a chartered statistician with expertise in statistical consultancy, biometrics project management, statistical programming, drug development and commercial business strategy.

Get in Touch

Lautrupsgade 7, 1. tv.,
2100 Copenhagen Ø, Denmark

+45 31 45 29 16

info@s-cubed-global.com

CDISC Training

Since 2007, we have provided authorized CDISC training in SDTM and ADaM, delivered by Johannes Ulander and Niels Both. We also host official training on behalf of CDISC, every year in our offices in Copenhagen (restrictions permitting), bringing together the full range of courses and expertise from across Europe. As members of the European CDISC Coordinating Committee (E3C), we are advocates for the CDISC standards and take part in the European Interchange each year.

Creating Values

The Future

We are at the forefront of the CDISC 360 project and are working on the development of Biomedical Concepts which will be at the core of the CDISC Standards. You can be assured that our team are ready to support you with any standards developments in the future.