When CDISC published Version 1.3 of its ADaM Validation Rules, a lot of you wondered what to make of it.
According to CDISC: “Some checks have been reworded for clarification … [and] 75 new checks have been added to cover rules not previously addressed. [These] additional checks cover the addition of checks for Adverse Events (ADAE) and the ADaM Basic Data Structure for Time-to-Event Analyses (BDS-TTE).”
To paint a clear picture of what all this means, and how the industry should respond, Pinnacle 21 hosted a recent webinar on this topic. The webinar — titled, “ADaM Validation Update from OpenCDISC” — provided an overview of these changes, and shared our experience of the most common issues in ADaM submission data observed across the industry.
The 2015 PharmaSUG Annual Conference, in Orlando, Florida, was an important and telling event. Pinnacle 21 was there, as both a presenter and exhibitor. The event drew more than 600 attendees, who generated a wealth of intriguing questions and discussions over the four-day stretch.
If you attended our programs, or witnessed the buzz of activity around the booths, then you saw what we saw: pharmaceutical software users who were eager to learn more about how to navigate FDA regulatory submissions in the months and years to come.
Pinnacle 21 ran two important programs to try to answer some of our attendees’ biggest concerns:
