Three questions with…
Kristine Klinger
Chief Delivery Officer
Kristine, uMotif’s Chief Delivery Officer, discusses her vision for uMotif’s services delivery organization and our culture of patient centricity and continuous delivery improvement. Kristine also provides some practical advice for companies interested in incorporating eCOA/ePRO technology.
What’s your most important advice for companies interested in incorporating uMotif eCOA/ePRO technology?
Understanding how you want to use the eCOA/ePRO data. When you look at an eCOA/ePRO system, it is a very cost effective and efficient strategy to fulfill regulatory requirements. Of course, to gain these efficiencies, the customer should first have in mind how they want to use this real-world data to support their claims or marketing data. As an example, identifying what is expected for the patient’s response to the medication (e.g., increased autonomy in daily activities), or how the physicians are using the device (e.g., ease of use).
It’s one thing to collect quantitative data that says a treatment is safe and effective, but it’s another to collect qualitative real-world evidence about the patient’s experience, that can really show a drug or device company how their product is improving their patient population and clinical outcomes, as well as the physician experience.
You see many protocols. What are the major trends, and what advice do you have to make the process more advantageous for sponsors and CROs?
My advice is to be open to the fact that using eCOA/ePRO changes how they will run clinical studies. If you’re a patient, you’re not in a normal situation when you’re going to the hospital for your 30, 60, 90-day visit. You’re stressed, driving through traffic trying to make it on time. That affects the results of your questionnaire. When you are home, taking your medication, you’re more likely to be relaxed in your normal environment when you answer the questionnaire.
Those different experiences present a huge opportunity for sponsors to gather real-world evidence that provides insight into how their medication or device is affecting the patient’s daily life. And of course, patients can easily take questionnaires multiple times a day or week throughout their treatment – not just at the 30, 60, 90-day visits – which can improve the statistical significance of the captured dataset without increasing study costs, and potentially shorten overall study timelines.
What’s your vision for the services delivery organization next year?
My mission is to always have raving fans. We have a culture of patient centricity and continuous improvement in the Delivery Services team to enhance our processes and advance the way we deliver a true white glove service. For example, in the last half of 2022 we ran several process improvement initiatives (i.e., Kaizens) and cut our delivery times in half. With our eCOA/ePRO technology consistently being enriched and our services team ready to support our continued steady growth, there’s no limit to what we can achieve for our clients’ studies.
Connect with Kristine on LinkedIn to arrange a meeting, or to discuss more about how uMotif’s eCOA/ePRO platform can transform patient engagement in your next study.