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.
What shift needs to happen to change this paradigm? To get the PM to be an extension of your trial team rather than a gatekeeper to more senior leaders? The answer is two-fold.
1) Redefine the PM Role
Instead of a junior role, IRT Project Managers (or as we like to call them Client Services Leads) should be filled by RTSM experts with years of industry experience, direct from sponsor organizations. They should bring to the table their own wealth of knowledge, ideas, and solutions. This is especially critical during the system build. With 100% configurable systems, there is an incredible amount of design choices. It is critical to work with someone that truly understands how a clinical trial unfolds to help advise on design parameters. In this way, they are problem solvers and advisors, not box checkers. They feel ownership and accountability to find solutions.
2) Apply Agile Principles to RTSM Software Delivery
Once you have an expert client services team in place, they should focus on what adds value with the goal of enabling higher quality systems. They must be able to adapt to a continuously evolving and complex industry by receiving, analyzing, and processing new information – all while leveraging their expertise to advise the client on the best path forward.
By delivering projects faster and more often, the lines of communication between the vendor and sponsor are strengthened. The client continuously provides input to refine the RTSM and in the same vein, the vendor provides feedback.
Start with an expert team. Layer on the focus on agile delivery and communication and you have a services team that is empowered to solve unexpected issues. That’s when you will want them to sit at the sponsor table.
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Kathleen Greenough, Client Services Lead at 4G Clinical, has 16 years of experience in life sciences spanning Clinical Operations, Finance, and IT. Her wide range of solutions implementation expertise includes RTSM, CTMS, trial costing tools, OLAP financial suites and patient enrollment planning. Kathleen has also...