PROCESS FOR PROMOTIONAL MATERIALS MANAGEMENT

Client Challenge

The client organization wanted to increase compliance by implementing one end-toend process for promotional materials management across all therapeutic areas. The promotional materials management process is complex and involves many functions within and outside of R&D. This process also includes vendors who support the development of the materials. Alignment of all key stakeholders is critical to program success.

Red Nucleus Solution

Red Nucleus led a cross-functional team consisting of regulatory, medical, commercial, legal, and R&D compliance representatives in developing an end-to-end solution. We conducted stakeholder interviews and workshops to define the critical process steps and detailed tasks accordingly. We also developed supporting core claims guidelines, templates, and standards.

Value

All key stakeholders were involved and aligned with the end-to-end process, which ensured a successful implementation. Guidance was also provided to external vendors to ensure their deliverables supported the process.