As a new decade begins and the clinical research industry continues to combat rising costs and complexity, patient-centricity has emerged as a central focus, transitioning from buzzword to reality. Decentralized trials and patient-focused technology like ePRO and eConsent are just a few of the tools that are beginning to show their value by positively impacting costs, timelines, and data quality.
Still, it’s not just about software and other technology. Having the support of a team of professionals who have walked in researchers’ shoes can go a long way in facilitating trial success. We take pride in our team and their contributions to earning Medrio a 98% customer satisfaction rating. Recently, we sat down with Lisa Charlton, a Medrio customer success manager with a Ph.D. in structural biology, an MBA, and more than half a decade’s experience supporting teams consulting on clinical outcome assessments and eCOA implementation and design. Here she shares in-depth insight into patient centricity, important ePRO/eCOA considerations, how her experience gives her unique capabilities to ensure customer success.
Medrio: Hi, Lisa! Can you tell us a little about your experience working in clinical research?
Lisa Charlton: Of course. After finishing up my Ph.D. in Biological Chemistry from the University of North Carolina at Chapel Hill, I became a postdoctoral associate at the University of Pittsburgh. There I studied the structural biology of proteins involved in the HIV-1 virus and worked mainly in the pre-clinical research phase.
After that, I moved on to ERT (eResearch Technology, Inc.), where I was introduced to the clinical space and supported teams who designed and developed novel patient-reported outcomes. As I worked with this team in my first couple of years, I learned a lot about regulatory guidelines, label claims, and endpoint strategy.
Later on, I focused more on electronic implementation and the regulatory guidelines behind it. My work revolved around questions like: What makes the best trial design? What makes enhances patient-centricity? What streamlines site workflows?
How has the work you have done in your Ph.D. and postdoc helped with the commercial work you’ve done?
I’m a constant student. The tools I gained in academic life – particularly critical thinking and the ability to look at problems in a highly detailed way – extended perfectly to my career in private industry. But beyond that, I’ve gained the vocabulary to understand deeply what research teams are trying to accomplish.
I’ve been on the other side of drug development where researchers study a drug signaling pathway or protein that stops cancer or inhibits a virus. That’s the aspect I learned during my Ph.D. My time at ERT just extrapolated into how do we study this within the human subject?
How do some of your experiences in the past translate into your ability to support customers and customer success?
I spent a lot of time in a sales enablement role, focusing on process improvement and operations specific to the collection of eCOA. Having so much close interaction with clients has allowed me to gain insights into their pain points. I learned firsthand from sponsors about obstacles at their sites – a central focus of my career has been understanding customers and helping to solve their problems.
Here at Medrio, something that enticed me is that EDC and eCOA are integrated. These complementary products give sites, sponsors, and Contract Research Organizations (CRO)s greater flexibility in approaching a study and accommodating site-specific workflow, patient experience, and seamless data integration for a data manager. I think the eClinical companies that will be most successful are the ones that address the personas of the site, data manager, and patient in a timely and cost-effective manner.
Medrio enables a BYOD approach with a web-based ePRO compared to a dedicated device model. While dedicated device models have advantages, depending on the trial, it may be much more fit-for-purpose to let participants use their own devices. We also embrace a patient-centric approach with our configurable software. A sponsor or CRO can quickly design, iterate, and enable both patients and sites to experience the software and provide feedback on whether it will fit seamlessly into the daily activities. Clinical trials are challenging; implementing electronic collection shouldn’t be burdensome.
What does customer success mean to you overall? How are we doing? From a customer success standpoint?
Customer success is good data with minimal pain points. No clinical trial will be without problems, so a responsive support system with proactive training is essential to a successful model whether you’re a site, sponsor, or CRO.
Medrio is unique. The onboarding, training, and customer support desk are some of the best in the industry. Proactive training and detail-oriented customer care are extraordinarily important because there’s nothing worse than picking up a piece of technology, trying to get it to work, and waiting and waiting on customer care. If people pick up technology and it doesn’t work, they’re going to move over to paper.
What are some technology, medical discovery, or future trends you’re excited about?
There’s a lot of talk about patient engagement. Regulators like the FDA are emphasizing a patient-centric approach. It will be interesting to see how that continues to take shape.
For sponsors to have a patient-centric approach, they need to consider how they’re going to collect data most efficiently and incorporate meaningful patient-reported outcomes into a protocol – which still takes a lot of planning to be done effectively. It will be more useful to shift the focus away from patient compliance and start thinking more carefully about engagement. Stop trying to force behavior. Let’s focus on getting good data by finding the key idea or understanding that makes the patient want to participate.
In terms of patient engagement, what are your thoughts on decentralized clinical trials? What are the components of an effective strategy?
I am a curious person and am definitely not an expert in regards to decentralized clinical trials – this concept is relatively new to me. Still, ePRO and DDC are phenomenal tools to support these activities – tech and mobility will be huge factors that ensure future success. Being able to collect data from a patient’s home or another place where they feel more comfortable is an essential factor in getting more reliable data.
Thank you so much for taking the time to sit down with us. We really appreciate it.