Summary
We provided the program structure and methodology that allowed our client to take corrective and preventive steps toward avoiding further regulatory sanctions.
Situation
A major pharmaceutical firm had been cited by regulators for problems with the comprehensiveness and timeliness of its reporting of adverse events. In response, the company assembled a list of corrective and preventive actions. As the list evolved into a set of projects, the firm needed to develop an underlying program management methodology and ensure consistent results from all initiatives.
Satori Solution
Working with an alliance partner specializing in drug safety, we established a governance structure and provided training in project management best practices. To determine the root causes of non-compliance, we introduced metrics for each step in the reporting process and developed a process to manage those metrics. We also set up a new compliance group to monitor and address the causes of late reporting and trained process owners to identify and report on late cases promptly. To find potential miscodings, we conducted a retrospective analysis of the reported cases. We then worked with the developers to create a database for case data entry review and analysis.
Results
Our client was able to standardize and improve its reporting procedures and tracking tools, positioning it to avoid further penalties through a more preventive approach to manage regulatory risk.