Low Quality Data Leads to High Cost
Cost and quality are often held in contention. Most would say you have to sacrifice one to get the other. Unfortunately, this has proven true in the Pharma industry as well. At both the DIA and BIO conventions, high cost of pharmaceuticals due to low quality data was a major topic.
Consider some of the statistics I gathered from a Risk Based Monitoring (RBM) session at DIA in regards to poor quality data and its effects:
1 in 6 FDA submissions have inaccuracies.
These issues typically cause a 14-month delay in the filing process. Just imagine the extra costs incurred by a delay of 14 months – not to mention lost revenue! A conservative calculation means this would leave over $252 Million of revenue potential on the table.
32% of first cycle submissions suffer setbacks due to poor quality data.
Flip that the other way – what if companies reported a 68% quality score? You wouldn’t see that number on any FDA filings.
It is clear that improved accuracy (quality) would save time and money – both of which would help patients and the industry. Shearwater Health has the high-performing clinical teams that can help ensure your data is safe, secure, cost-effective, and accurate. We have found time and time again that our clinicians perform at the highest level of quality and accuracy because of the Six Sigma training and reinforced management support they receive.
Learn more about our services here.
Chief Revenue Officer