The Good Data Submission Doctor: Should I Stay Or Should I Go?

By Angelo Tinazzi, Sr. Director, Standards, Systems, CDISC Consulting, Statistical Programming, Cytel Inc.

A recurring question we get from our clients is whether it is worth adopting data standards such as CDISC in the early phase of their drug development, and if it is worth spending more to produce SDTM and ADaM packages at an early stage. This question is usually a concern of small biotech not wanting to "risk" money without knowing (yet) the future of their compound.

It's an easy question (for me) to answer: yes it is worth adopting the standards from the very beginning for the following five main reasons: