We share our knowledge and insights about industry trends and market developments in pharmaceutical product life cycle management.

A privately owned, rapidly growing pharmaceutical company was charged with rolling out 22 releases for a multi-product launch in one year’s time. In the early stages of the program, the client struggled with a series of issues that,…

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…

Within hematology, Higher Risk-Myelodysplastic Syndrome (HR-MDS) and Acute Myeloid Leukemia (AML) are diseases with a highly unmet treatment need. In response, an NJ-based pharmaceutical leader created an innovative new immune-modulating treatment that shows tremendous promise in the fight…

When two large pharmaceutical companies merged, the study teams struggled with a lack of clarity over which operating models to follow for their respective studies. With heritage procedures and IT systems in place across both entities, and pros…

Project management challenges exist at all levels of the organization—from the highest strategic level down to the project task level. In today’s business environment, an organization’s ability to recognize and resolve those challenges is a crucial driver in enhancing business…

CMK Select is pleased to announced that it has been recognized by NJBIZ as a finalist for 2020 Business of the Year. Each year, NJBIZ recognizes the state’s most dynamic businesses and business leaders who share a commitment to professional…

According to the PMI’s 2020 Pulse of the Profession, the average project wastes nearly 11.4% of its funding. Organizations that undervalue project management as a strategic competency are the hardest hit, enduring a staggering 67% project failure rate.* Project management…

In a recent article, Risk Management and Disaster Recovery in the Age of COVID-19, we discussed how we can gain valuable risk management insights by first looking at the likelihood and impact of a given risk and then drilling down…

Our previous posts in this series reviewed the history and evolution of Medical Affairs departments in the pharma industry, noting how the growth of these departments led to an increasing need for project management expertise. We then explored the ways…

In our prior article, we discussed the history and evolution of Medical Affairs departments, and reviewed how these departments have grown to perform so many integral functions within pharmaceutical companies. We also observed that, as Medical Affairs’ work streams have…

A pharmaceutical technology company originally created a tool to validate the safety of medications, and while the tool effectively met the initial goal, after two years of use, many end-users wanted more automation, less paperwork and greater efficiencies.…

In prior articles, we have discussed the critical role played by pharmaceutical companies’ Medical Affairs departments, particularly related to product launch preparations and execution. Now we’ll examine the growing importance of project management within Medical Affairs departments. The great separation…