Matt is a Senior Solutions Architect in SAS’ Health & Life Sciences business unit, where he focuses on data transparency and drug development issues. Prior to joining SAS, Matt spent over 20 years in statistical programming roles at a number of Clinical Research Organizations.
The regulatory submission process in life sciences is becoming less about assembling documents and more about proving trust. For years, submission readiness was largely treated as an end-stage operational milestone: finalize the analysis, validate the outputs and package everything for regulators. But that model is beginning to break down under
Collecting, managing, standardizing and analyzing clinical data during (and after) a clinical trial is crucial in the process for submission and regulatory approval of a new compound, biological, device or other therapy. A central clinical platform requires: Robust and auditable analytics to prove the result to the authorities and external
