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Satori orchestrates change; we deliver insight, add clarity and align business objectives to yield results. We go beyond the obvious and search for innovative solutions, working side-by-side with our clients to implement them.

Measuring and monitoring regulatory compliance

We developed metrics and monitoring processes that helped our client develop a proactive approach toward compliance with regulatory guidelines, positioning it to avoid sanctions and adverse publicity.

The Situation

A global pharmaceutical company had been informally warned by regulators about shortcomings in the comprehensiveness and timeliness of its reporting. One particular problem was that too many adverse event cases were being submitted late to regulators. In order to identify the root causes of non-compliance and improve its adherence to reporting timelines, the firm needed to identify compliance metrics and design a monitoring process to capture metric data.

The Satori Solution

Satori worked with an alliance partner specializing in drug safety to implement a monitoring process that could identify the divisions responsible for late reporting and the reasons for lateness. We established metrics for each step in the reporting process developed methods for managing the metrics. Next, we worked with the firm's technical team to design and build a tool that captured the reasons for lateness, the associated corrective actions, and the identity of the division responsible for each late report. We used this data to identify the root causes of late reporting, to track improvements, and to examine the efficacy of corrective actions.

The Results

The new monitoring process helped our client develop a preventive approach to late reporting. This has resulted in improved compliance and reduced short-term risk exposure.