Reimagining the digital experience for clinical trial operations.

A person with cancer has many potential treatment pathways, one of which is participating in clinical trials. Though these are typically managed by pharma companies, a large ecosystem people is involved in the clinical operations that make them run smoothly and potentially provide life-saving care. When genomic profiling is involved, trial sponsors will partner with a company like Foundation Medicine for key milestones, testing patients both at candidacy screening, or other key visits. The tools used to foster clinical operations between Foundation Medicine and pharma partners play a pivotal role in ensuring patients are cared for properly.

The Challenge

After receiving genomic profiling as part of a trial, results were being delivered to pharma partners and their contractors, using an off-the-shelf solution that was technically unreliable, frequency missing results or time-sensitive notifications, and rife with errors that could cause potential data breaches.

For Foundation Medicine, it was also unsustainable because new instances of the same portal were built for each new trial and partner, leading to a large number of separate portals to maintain. A unified solution was required; one that was easier to use, more secure, and scalable enough to accommodate new feature requests from pharma stakeholders.

My Role

I was the lead designer, partnering with, Product, Engineering, and our Clinical Operations team to re-envision our partner portal and bring it up to parity with our other customer-facing tools. Starting as a solitary contributor, I did the discovery, due diligence, and initial prototypes for testing.

After being promoted to manager, I led two staff designers as we built and launched the new tool, working in phases to roll out two critical new features: sample tracking, and error handling.

Business Goals

Consolidate all partner portals into a unified solution, under one login
Bring the partner portal up to visual and functional parity with our commercial offerings
Create a foundation for scalability and continued iteration & improvement, including order tracking, self-service issue resolution, and digital ordering.

Impact

High-priority processing issues resolved an average of 3 days faster.

Discovery

Understanding a new user-base.

Users of our partner tools differed from the customer facing tools we had formerly been designing for. We started doing internal research with our biopharma and clinical operations teams to align our understanding of the clinical research ecosystem, the user base and the most common pain-points from a user and business perspective.

Workshops to map out what each user type needed, how their work impacted one another, and what success or failure looked like.
Facilitating stakeholder agreement on who the primary users of the new experience would be, and how we might prioritize feature development as a result.

- Stakeholders on the pharma side would be high-level users, but the day to day use of the portal would fall to teammates who were located at hospital sites, or employed at third-party research organizations (CROs). This made it difficult to access direct users for testing, and forced us into double-blind recruiting with an outside agency.
- Balancing feature requests from trial stakeholders against the needs of day-to-day users, who span several different titles and levels of training/experience.
- A clear set of features, prioritized by impact to the business and our partners.
- A clickable prototype used for testing, and to socialize our plan to internal and pharma stakeholders.

Process Map: Existing workflow for trial admin and data/result delivery

Workshop Output: Research needs by audience type

Workshop Output: Relationship map of internal and external portal users.

Workshop Output: Capturing stakeholder and SME perceptions of audience

Delivery

Validate & Iterate

Managing a team of two designers, we first built low-fidelity testing materials to leverage in research sessions, then a new prototype, aligned to our existing design system.

A large portion of this work also involved change-management with Foundation Medicine’s pharma partners. Together with stakeholders in ClinOps, I led discussions and prototype demos with 5 of our largest pharma partners, socializing the new work and collecting their feedback.

- Regulatory (CLIA) requirements often forced us to add steps to what would have otherwise been a more efficiently designed experience.
- Technical limitations with our CRM limited our ability to affect change on the scale we originally wanted. As a result, some error handling had to remain manual.
- A new partner portal was eventually built, with more secure report delivery, live sample tracking, and an online error handling system that cut the time to get samples back into processing by [get stat]%.