Applying the Scientific Lens to Clinical Research Technology: The Chief Scientific Officer Perspective

By: Florence Mowlem, PhD, Chief Scientific Officer, uMotif 

Last month I celebrated my first anniversary as Chief Scientific Officer (CSO) at uMotif, and I’m excited about the year ahead. While the CSO role is well established in the pharma and biotech industries, it continues to evolve in the world of clinical research technology. And that dynamic makes my job even more interesting. 

As CSO, every day is different. I might be reviewing a new study opportunity and providing a recommended solution for the data capture or working on the design of a home-grown, event-driven eDiary. Or the day might bring preliminary testing of a study solution we have built before the client does their user acceptance test (UAT) followed by working with the design and product teams to ensure a new feature is optimal for its intended use case.  

As varied as any day may be, my top priority is always ensuring the best application of our technology to help our clients achieve scientifically sound, compliant, and successful studies.  

So, what does my job really entail? While each day is filled with diversity and new opportunities, my role spans four primary functions.  

The first is reviewing incoming study proposals and providing recommendations about the best digital data capture solution for a study. There’s so much more to this than just thinking about the actual COAs that are being used in a study. One must also consider where data capture is taking place—whether it’s remotely or at a site—and what device types are being used. I’m really thinking about the participant and site experience relative to the workflows we are proposing. This insight can be especially important to smaller organizations that don’t have dedicated teams with deep knowledge and experience in this area. 

Once we’re awarded a study, my focus is more internal, working cross-functionally to ensure that all teams understand what has been scoped during the proposal process. I also work with the solution design, technical, and project management teams to be certain that all are aligned around the study protocol, the solution that we’ll be delivering, and specific design considerations for the trial. When sponsors look to include more complex measures or homegrown eDiaries, I provide input and design support for these specialized tools.  

One of the most critical parts of my role is ensuring that the scientific lens is incorporated into our work, including new product features. When the product team is scoping out new product features or functionality, they convene various stakeholders to ensure that what we’re building will meet the needs of a clinical trial and integrate as seamlessly as possible into the users’ day-to-day lives—in the case of a patient or caregiver—or daily workflow, in the case of site teams. I work to ensure the scientific suitability of new features as well as provide insight on usability from the perspective of patients and site personnel. 

Finally—but certainly not least among my responsibilities—is the research aspect of my role. This involves thinking about the systemic pain points in clinical trials that I see in my everyday work and how we—both uMotif and the industry as a whole—can help to solve them. This might involve working with the Critical Path Institute’s eCOA Consortium on a scientific paper or study focused on a specific issue and how we can collectively drive the industry forward to optimize the conduct of clinical trials. This function is one of the most interesting and fulfilling aspects of my role at uMotif. 

The importance and challenges of the scientific perspective 

I’m responsible for bringing an independent scientific perspective to my work. This philosophy is critical to building credibility and trust with our clients. It also can present some interesting situations. 

For example, the role of the technology teams is to say if we can support something from a functionality perspective. My job is to decide if we should do it. Sometimes that casts me as a “No” person.  

I’m also always very clear that the ultimate decision on a study design approach lies with the sponsor, but I will present my recommendations based on my experience in the field and supporting similar trials, and my expertise regarding clinical trial design— especially with regard to introducing digital data capture methods.  

Ultimately this perspective is very important for uMotif. We are committed to being an organization that partners with our clients and is known for the trust that we build with them. Our clients consider us a trusted partner—not simply a vendor—who is vested in their success. Candid discussions and open dialogs of this support are essential to this goal.