A tool in Japan used by oncology sales representatives to track sales visits and customer information was identified as having potentially reportable safety information. Consequently, the local country office needed to review of all available data and conduct new benefit-risk analyses on any products with previously unreported adverse events. Our client also conducted a root cause analysis identifying several areas for improvements to prevent future instances of non-compliance.
The Satori Solution
A cross-functional project team was established to address the local Japan issue and assess the use of sale representatives’ tools globally. To resolve the issue locally, we provided project management support to the local corrective actions, which included conducting Medical Representative-specific training, changing medical representatives’ job descriptions, and creating new relevant policies and procedures.
We then designed a strategy and process to methodically evaluate the content of these tools and ultimately execute the extraction and sampling. We reviewed 200 tools throughout the world containing an estimated 102 million records of customer interactions between sales reps and healthcare professionals. Concurrently, we established a Project Management Office, including governance, charters, and project plans, to oversee the development and implementation of various global preventative measures, such as new training and the development of a new cross-divisional policy governing the use of these tools.
We completed the assessment on time and our client was able to report effective management of the issue to regulatory agencies globally.