Research & Safety Interface

The client approached us with the ask to empower compliance with healthcare regulators and ensure that use of product documentation becomes auditablesacross all clinical studies.  In order to understand the magnitude of the challenge, identify the right business areas to reimagine, and proof the potential value of a future solution, my team and I have taken an explorative approach. The project was planned and delivered fully remote.

With a core team, consisting of a senior solution and a senior business consultant, I have framed the opportunity in order to create actionable work streams and orchestrate the project. At the solution creation phase, we scaled the team to deliver a proof of concept and receive approval for solution build. In the second phase of the project, I have initially led an interdisciplinary team of consultants, client stakeholders and designers until the design for the MVP was production-ready.

We conducted various interview, framing and walkthrough sessions to obtain a macro-view on the business area, understand the underlying clinical-trial processes, analyse stakeholders and their needs and identify personas and pain points.

The produced insight were harnessed to empower the client´s business-IT team, and instigate decision-making to transform this area of business.

Once we understood the end-to-end process, we identified and zoomed-in on the critical areas for compliance and audit. This allowed us and the client team, to determine the initial scope for the future solution and served as starting point for prototype design and development.

For the selected focus areas we redesigned the process to become more efficient by streamlining and automating process steps. Further, we incorporated capabilities to become fully auditable. Based on a story board, a team of 4 developers, delivered a functional proof of concept with real customer data, within 2 weeks time.

After the PoC, the scope of the solution was extended to 4 user roles and 3 functional areas. To design all user-interactions for such a complex system, we took a system-focused approach to satisfy all stakeholder needs.

Through multiple co-creation sessions with end-users and IT stakeholders, we designed the future end-to-end business process, determined system artifacts and defined the integration interfaces with other systems.

Having the global business process designed, we created an application flow that reflected all process steps. This flow was translated into role-bases sequences, that served as a basis for wire-framing and solution validation.