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.
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.
We have advised, trained, and implemented CDISC 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.
Members of our CDISC team
We are CDISC Authorised Trainers in SDTM and ADaM.
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.
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.
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.