The U.S. cardiovascular team of a global pharmaceutical company needed help responding to a new Corporate Integrity Agreement for two launch products. Resource-constrained at the time, they were looking for a streamlined and efficient way to satisfy the strict government-imposed deadlines without blowing their budget or delaying the products’ launch dates. The client turned to their trusted partners at CMK for strategic guidance and support in addressing this immediate need.
The CMK team began by exploring creative ways to use the client’s existing procedures and compliance and regulatory documentation to meet the new requirements while delivering long-term efficiencies. They made process improvement recommendations, built templates, created guidance documents and defined a more streamlined approach for meeting deliverables more efficiently. In collaboration with the client’s key stakeholders, the CMK team then developed planning documents and configured them to perform automated tracking and reporting around tactics, budgets, priority, business case, changes, timing, dependencies and more.
With newly streamlined procedures and enhanced documentation in place, the additional checkpoints were implemented on time and did not impact the client’s budget or launch timelines. The tracking and reporting functionality allows the project teams to have more meaningful, data-backed discussions with stakeholders, while the automation capabilities make it easy to uncover areas of opportunity and track progress for continuous improvement. Today, the client is equipped with repeatable processes that help them ensure ongoing compliance with all policies and procedures and transparency with internal and external constituents—and also serve as a best-practice that can be shared across other therapeutic areas.