Should Vendor IRT Project Managers Sit at the Sponsor Table?

The Power of RTSM Problem Solvers on your Team

You spend an enormous amount of time assessing technology vendors through RFIs, pilots, and capability presentations. Not only must the technology fit your needs, but you also make a judgment call based on the trust and value of the future relationship. Ultimately, the decision may weigh in favor of someone you can envision your team working well together.

Given how important that relationship is to the success of your studies, should your Project Manager (PM) have a seat at your table when it comes to trial decisions and strategy?

They should- if they are qualified. Unfortunately, the PM that is assigned to your account may not be the person you met during the vetting process (and were so excited to work with!) and, what is worse, they may not have the expertise to truly sit at your table.

Let me explain.

A typical PM role at a technology vendor is not a very experienced position. They may have little to no knowledge of clinical trials and/or the complexities that randomization and trial supply management (RTSM) addresses. RTSM are arguably the most complex and critical of eClinical systems. They allow sites to dispense drug to patients, which can have real consequences if not done properly. Why then, are these roles given to PMs lacking depth of industry expertise?

In my experience, it’s not that the work isn’t getting done. It does, however, create two issues. One, it enables a culture of box-checking. PMs are responsible for keeping track of an immense amount of data and that is compounded by an industry that is constantly evolving. The result is at the end of the day, tasks are completed as defined by a company’s procedures without a critical eye toward process improvement. No one is providing suggestions and solutions from past experiences. The good news is the client is always right. The bad news is that there is never a dialogue to bring in fresh ideas.

Second, any issues must be escalated through the organization, and solutions are brought back down to the client-facing staff. Simple questions take longer than they should to address and the responsiveness from the vendor to the client is at risk.