Tag: Compliance

Pain Points

• Mid-sized specialty pharmaceutical company received six warning letters in a four-year span from the FDA as a result of a highly ineffective process to approve promotional materials internally
• Communication and interaction between various Marketing groups and the Medical, Legal and Regulatory departments was strained
• A new promotional materials management process was designed by an outside vendor but had not yet been implemented
• New process rollout also coincided with the rollout of a new customized IT system built for the review and approval of promotional materials
• High anxiety was present at the organization as a result of the departure from the “old way” of approving promotional materials

Our Solution

• Cross-functional key change agent “Champions” team was identified and assembled to ensure the new process was followed within their respective business groups
• Performed resourcing analysis and recommended additional Commercial Operations department headcount
• Communications Strategy and Plan were developed
• Initiative logo and tagline were created and embedded in marketing vehicles to create awareness internally
• Stakeholders were identified to assist with the dissemination of targeted messages coming out of the Communications Plan
• Team-building events were coordinated to optimize the new process and improve the organizational dynamics of the promotional materials reviewing teams
• A reward program was established to recognize high performers and reinforce positive behaviors

Benefits Realized

• Champions team structure put in place was “highly effective and helped enormously in circulating clear, properly branded messages” that highlighted the new process benefits and ensured two-way communication and feedback
• Role clarity, improved personal relations, team-work and communication between the Medical, Legal, Marketing and Regulatory departments “made a big difference in improving the quality of the submissions”
• Promotional materials were managed more “smoothly and efficiently” resulting in less issues down the line
• Adoption of the new process resulted in “quantifiable improvements to process metrics and palpable improvements in the culture”
• Number of warning letters from the FDA was significantly reduced to zero throughout the four years following the implementation of the new promotional materials management process

Pain Points

Our client had recently acquired a smaller pharmaceutical company and needed a strategy to ensure data and R&D systems from the legacy organizations was properly integrated.

Our Solution

In collaboration with system and business process owners from the legacy R&D and IT functions, our consultants developed a strategy and roadmap for integration. Our team:

• Identified and mapped all legacy systems and their owners
• Identified data contained in systems and some that was not in the systems
• Identified the business processes supported by the systems
• Documented gaps and limitations of each system
• Using the information we collected, we developed an integration roadmap and strategy that identified the systems to be sunsetted, how data was going to be integrated, and the plans and schedule for transitioning. In addition, the team highlighted the business processes that were going to be impacted by the integration strategy for the organization to develop appropriate contingency plans.

Benefits Realized

In addition to many other non-tangible benefits, the R&D organization:

• Initiated a step-by-step plan to transition information
• Transitioned in a compliant manner with limited disruption to business activities
• Consolidated redundancies to develop single sources for business critical information