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.
Our CDISC team
We are CDISC Authorised Trainers in SDTM and ADaM.
Managing Director & Consultant Statistician
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.
Our training in SDTM and ADaM, delivered by Niels Both, is available to clients worldwide. We also host official training on behalf of CDISC, most years in our offices in Copenhagen, bringing together the full range of courses and expertise from across Europe. We are advocates for the CDISC standards and take part in the European Interchange each year. If you have any questions about our training programs, please get in touch and we will be happy to answer your queries or arrange an initial conversation about this topic.