If you’re a biostatistician or clinical software developer, you’ve probably felt the weight of trying to meet GxP standards while navigating the FDA/EMA submission process. It’s not just about getting the software right—it’s about ensuring safety, quality, and compliance, all under tight timelines. It ...

GxP validation can be a complex and often misunderstood process, with each company implementing their own unique approach. During a recent roundtable I attended at the R/Pharma Summit in Seattle, there was a recurring theme that stood out to me – every company seems to have their own definition of ...