After the acquisition of SnapMD by VirTrial, we began transforming a telemedicine product built for healthcare to serve new use cases in the clinical trial industry. The virtual visit remained at the product's core. However, we now had new personas, including study participants rather than patients, principal investigators rather than clinicians, and various new roles, including study coordinators and study monitors. We supported unique needs with the existing product by expanding user permissions and modifying core workflows.
To truly serve the needs of this industry, however, it became clear that we needed new tools to supplement the virtual visit. Before a study could begin, the sponsor needed to assess all clinical sites for that study to ensure compliance and readiness. Before participants could begin the study, they needed to complete the informed consent process. In addition to investigators entering assessment data, studies require periodic input directly from participants. Thus we set out to develop a line of products, all running on the same platform to serve the different phases of a clinical trial throughout its lifecycle.
Virtual Site Monitoring
Product Summary
VSM was a innovative concept for the clinical trials industry that became especially relevant when study monitors could no longer travel to and inspect physical clinics in person during the COVID pandemic. In the traditional model, which is both time-consuming and expensive, a study monitor physically visits each site being considered for a study.
Our product consisted of a kit that contained a mobile device and a pair of proprietary glasses with a camera. We shipped this kit to a site. The study monitor scheduled a virtual visit and, during the visit, a study coordinator onsite wore the glasses and acted as the "eyes of the study monitor."
Product Accomplishments
When I began work on this project, our engineering team had completed a proof-of-concept. The next step was productizing the technology and finding product-market fit. My role was primarily as design lead and product owner. I worked closely with Deric Frost, the general manager of the initiative. He handled the effort's commercial, marketing, and product management aspects. Together we launched a beta of the product within eight months.
My role in the evolution of this product:
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Design and prototyping for the mobile app on devices shipped to sites.
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High-level design concepts and prototypes for the web app used by study monitors to complete and manage site assessments
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Design lead for product designers designing high-fidelity mock-ups
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Design input during design reviews with the firm in Belgium designing the eyeglasses with a camera
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Maintained feature roadmap, wrote requirements, and negotiated trade-offs to keep us on track to realize a beta version of the product.
eConsent
Product Summary
While we had an excellent foundational product for running decentralized clinical trials in Virtual Visits, it became clear that we also needed a product to facilitate the informed consent process. Informed consent is a critical compliance process that ensures the study participant understands what is required of them by agreeing to participate in a study. Participants must consent before any other activity in a study takes place. While clinical sites traditionally manage this process using paper, we saw an opportunity to complete the process electronically.
Rather than rebuilding existing consent documentation as new content in a system, we took the approach of uploading a PDF of the existing consent documentation and using controls to activate aspects of the document that were needed, such as text input, selections, and signatures so that site staff and participants could complete the consent process using a web browser or mobile app from any device with an internet connection. We aimed to offer an expedient, affordable solution that reduces errors and improves compliance.
Product Accomplishments
We launched our consent product as eConsent Silver shortly after Signant acquired us in March 2021. I shepherded our eConsent product from concept to launch in ten months. I functioned as the product manager, design lead, and product owner throughout the evolution of this product.
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Researched compliance and industry needs to develop product requirements.
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Created high-level design concepts, flows, and web app prototypes during the research and scoping phase.
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Design lead for product designers bringing designs to high fidelity.
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Maintained feature roadmap and negotiated trade-offs to keep us on track to realize a beta version of the product.
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Wrote 21 CFR part 11 compliance documentation and managed effort to complete validation of the product before launch.
See the press release for details:
Signant Health Announces the Release of Expanded and Enhanced eConsent Solutions