CDISC

As CDISC authorized trainers in SDTM and ADaM, we provide expertise about requirements, processes, systems, as well as consultants experienced in implementing these standards.

We have advised several major pharmaceutical companies all the way from first steps of implementing CDISC through to full implementation. S-cubed’s consultants have converted over 100 studies to CDISC standards and supported more than 20 successful FDA submissions. Having worked with CDISC standards since 2004, we are very familiar with issues that typically arise and have unique insight about what works well.

The United States Food and Drug Administration recommends using CDISC (SDTM) standards for electronic submissions of all clinical data, and requires compliance with CDISC standards for all new clinical studies starting after December 2016. The European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency have also expressed intention to require CDISC.

In 2017, we formed our partner company A3 Informatics. Working with Dave Iberson-Hurst, A3 Informatics have developed The Glandon Suite. A3 Informatics designs tools to solve real world challenges in a non-disruptive and iterative manner to suit different working environments. Our CDISC team are working closely with A3 to ensure that clients are able to leverage the CDISC standards to deliver high quality data throughout the clinical research process. You can learn more about A3 Informatics and their services on the A3 Informatics website.

We are CDISC Authorised Trainers in SDTM and ADaM.

Registered Solutions Provider

Education

Software Solutions provided by

100+ studies as part of NDA submissions

OFFICIAL CDISC Registered Solutions Provider

100% accepted by the FDA

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.

Carey Smoak

Principal Consultant

Carey joined S-cubed with over 30 years of SAS programming experience. He is co-founder and co-leader of the CDISC Device Team which has developed 7 new SDTM domains for medical devices. He has successfully programmed/managed more than 20 regulatory submissions which have resulted in clearance/approval of FDA products: includes NDAs, BLAs, PMAs and 510(k)s. He is also experienced in ADaM and CDASH.

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.