Pavel Samsonov

Clinical Risk Monitoring

A leading biopharmaceutical company turned to AWS to help develop its next generation clinical risk-based monitoring tool. I designed a single-pane-of-glass solution that put actionable data in front of study monitors.

    My roles

  • drove opportunity definition to build stakeholder trust and establish a shared mental model of the future state
  • organized co-design process with subject matter experts to create a maximally tight feedback loop and accelerate iteration
  • led 0-to-1 design of both the monitoring platform and the workflows integrating it into existing clinical study processes

    Product impacts

  • 15×
    5× faster initial response times through helping study teams catch issues CRMs missed
  • 73%
    73% better SLA compliance due to improved monitoring of CRM (Clinical Risk Monitor) activity
  • 18%
    18% reduction in delays overall by accelerating issue identification and resolution
  • 99%
    99% less time spent on risks, allowing study monitors to use time more productively

A new approach to clinical studies

As the customer's research teams began to adopt clinical risk monitoring for their study protocols, they came to realize that their existing tools were not fit for purpose. My team worked with the customer's leadership and clinical researchers to define expectations for a new platform that would reduce the time teams spend looking for potential risks and increase their ability to resolve identified issues.

Opportunity scoping
  • Clinical study teams
  • Governance
  • Product leaders
Iterative design
  • Executive alignment
  • Journey mapping
  • Solution hypothesis
  • UX design & user testing

In addition to the typical demands for a dashboard, our research showed two problems that would need to be addressed. Because risk-based monitoring was a new approach, few research teams had a good understanding of what it entailed. While the company contracted dedicated clinical risk monitor (CRM) companies to observe study sites, study teams had no way of ensuring that the CRM was doing its job.

The team can see an overview of the study’s health and the status of all open issues. Unassigned and stalled issues are highlighted so that they can immediately take action.

I designed an experience that would be approachable to teams that didn't yet have a robust understanding of risk-based monitoring, that would guide study leads through selecting the appropriate risks for the study protocol and show them trends in key risk indicators across the study. The platform allowed them to immediately spot issues that could undermine the study's viability or patient safety, drill down into the data to understand the issue, communicate with the on-site CRM to address it, and issue regulations-compliant reporting.

Directly from the dashboard, a user can dive deep into an individual risk, KRI, issue, or filtered cross-section. The data is visualized to help them immediately identify outliers and trends.
The study team can see the issue owner action history. If a new action is necessary, the study team can send a request to the owner directly from the tool.
The platform designed takes into account the roles of the Study Lead and Study Team as well as those of the CRM, to ensure the integrity of the end-to-end process.

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