Z-factor Approach: Inspiring Confidence
In the world of pharmaceutical clinical trials, success depends on many factors, but one stands out as a crucial cornerstone – robust data to meet regulatory guidelines. The Z-factor is a statistical measure used to evaluate the quality of an assay or screening method. Throughout the drug development process, scientists encounter an accumulation of variability from multiple sources. The lower the variability, the higher the percentage of batches that meet the required standards. To reduce sources of variability in bioanalysis, our late founder Dr. Rao Marepalli institutionalized “Our Z-factor Approach”. through which we implement high-quality systems and processes to provide sponsors with the high accuracy and low variability data. How to we do this? Extensive Quality Systems resulting from over 200 audits. Top-notch equipment maintained by manufacturers. Extensive Quality Systems resulting from over 200 audits. This is the robust data that allows you to make informed decisions about the safety and efficacy of your pharmaceutical products. It’s the foundation upon which you build your path to regulatory approval and ultimately, bringing life-saving medications to patients more swiftly. Sannova has not only managed to maintain an ISR pass rate >90% with Our Z-factor Approach, but we have helped hundreds of clients successfully bring biotech or pharmaceutical therapy to market. Z-factor data in pharmaceutical clinical trials is not just a requirement; it’s a strategic advantage.