While providing SEND-ASSURE services for checking Conformance, Consistency and Quality of SEND data sets we continue to see significant gaps in readiness on the part of preparers such as CROs and sponsors who need to stand behind these SEND datasets when submitted to the regulatory agencies. We have compiled metadata about these three KPIs for a dozen (12) studies we have assessed under our SEND ASSURE program over the past couple of months. These are normal operational results from our SEND-ASSURE program and do not include any “first-time” studies that were assessed to benchmark a client or data preparer. The summary is included in the paper. The numbers indicate the number of egregious conformance, consistency or quality issues that will affect the submit-ability or reviewability found.
The three indicators we consider are, together, an indicator of how ready a sponsor or data preparer is to meet the mandate in place today. While some of the studies had “0” Conformance issues, or “0” quality issues – NO studies were without Consistency issues. One study that had “0” Conformance and Quality issues, in fact, had the highest number of Consistency issues. Watch for periodic updates on our website as we share the latest statistics on these quality indicators and use them to benchmark your organization and process. We have provided a description of the three indicators and what steps can be taken to improve performance in each.