Simplifying Ethics Compliance Handling Process Mitigates Drug Company’s Risk

PROJECT BACKGROUND

A major pharmaceutical company embarked on an initiative to simplify, streamline, and improve the effectiveness of their internal ethics compliance processes, procedures, and forms. The company anticipated that cultural norms and organizational silos would pose significant obstacles to reaching this objective. Further, management clearly recognized that continued ethics violations presented a significant liability to the company and needed to be minimized. They believed that if the compliance processes were made clear and concise, this risk would be mitigated.

IPM’S SOLUTION

Integrated Project Management Company, Inc. (IPM) was enlisted to provide professional project management and consulting services to map the current ethics processes across key business units; analyze and identify inefficiencies and misunderstandings; and provide process optimization recommendations that could be implemented and leveraged throughout the company.

IPM established a project core team of key business leaders and began conducting a series of interview sessions. This facilitated the drafting of process flow diagrams of activities currently utilized to ensure compliance to ethics policies, highlighting the functional activities and required forms. IPM performed a series of analyses to identify disparities and gaps between the process activities of each business unit’s functional areas as well as across business areas.

IPM’s analysis revealed that 30 different processes and 22 different compliance forms existed across all business areas and were used to manage day-to-day ethics compliance activities. IPM developed an immediate improvement recommendation to reduce the processes and forms by half.

In addition, IPM conducted brainstorming sessions with each business unit’s functional management group to capture interdependencies between functions and identify process improvement opportunities. These brainstorming sessions were critical in “breaking down” silos and promoting improved communications across functions. IPM’s objectivity proved to be beneficial in stimulating open communications, building team unity, and confirming buy-in to optimization recommendations made. This ultimately facilitated team ownership and confidence in implementing the simplification and streamlining opportunities.

IPM reviewed the summary of the process maps, key findings, project conclusions, and final recommendations with the project core team. This ensured a mutual understanding of the current ethics compliance processes and inefficiencies, and established alignment for effective implementation of the simplification and streamlining recommendations.

PROJECT RESULTS

As a result of IPM’s involvement, the ethics process improvement recommendations are expected to yield:

  • Improved understanding of ethics compliance rules across all functional areas
  • 10 – 20% reduction in time required to complete ethics compliance forms and supporting documentation
  • 70 – 85% improvement in ethics compliance training and processing time
  • 80 – 90% reduction in paper “handling”
  • 25 – 50% increase in knowledge sharing across key business areas


Importantly, because the company now had a streamlined and visual means to explain their ethics processes to internal and external audiences, they were confident that they would see a significant decrease in the number of ethics violations and time spent mitigating them.