Back to Courses
Go to Professional Development

Platform Transformation

Background

Revolutionizing Clinical Research Management

I led the redesign of a digital platform transforming how research sites manage critical studies. Think of it as mission control – where documents, processes, and compliance requirements converge into one seamless system.

Expanding User Base

‍Our site-focused platform began serving sponsors and CROs, introducing complex new use cases and requirements that our existing system wasn't designed to handle.

Meeting Growing Demands

As clinical research evolved, our users needed more than document storage. They demanded intelligent workflows and rich data insights, catalyzing a complete platform reimagining to create something more powerful and intuitive.

Goal

While the design strategy appeared straightforward, executing simplicity at scale proved to be complex. The new site enablement platform aimed to:

• Mirror real-world concepts and terms
• Support diverse organizational scenarios
• Balance structure with flexibility
• Ensure intuitive usability
• Provide built-in insights
• Simplify setup and configuration
• Streamline roles and permissions
• Enable workflow personalization
• Implement Universal Design principles

Challenge

The task of innovating and replacing an entire suite of clinical research products presented both excitement and significant challenges. Our team recognized the importance of establishing a solid foundation while maintaining the flexibility to reassess and adjust priorities throughout the development process.

Approach

As lead designer, I spearheaded a comprehensive analysis of our flagship electronic document management tool. My investigation revealed fundamental limitations in the existing architecture that couldn't support our evolving user needs.

I leveraged the OOUX (Object-Oriented UX) framework to reimagine the system's foundation, collaborating closely with product, innovation, and technology teams. This strategic approach to solving core structural problems resonated so strongly that it became the company's top priority.

Process
Object Model

Building the Foundation

We began by crafting a comprehensive object model to define the system's core structure. Through extensive collaboration with stakeholders and subject matter experts, we mapped out the fundamental building blocks that would support our evolving platform.

object model listing orgs, studies, study sites, users and documents

System Overview

The high-level system architecture illustrates how the platform operates across three key levels: Internal System, Organization System, and Study Lifecycle. This layered approach shows how we support everything from user management to study execution – from initiation through completion. The design accommodates the full range of workflows, including study setup, active management, and archival processes.

Creating Dynamic Connections

Our model went beyond basic relationships – we designed a system where data flows intelligently between objects, automating repetitive tasks and streamlining workflows for users.

Smart Attributes & Permissions

Each object contains carefully defined attributes that enable:
• Intuitive navigation between connected elements
• Simplified user permissions
• Automated data exchange
• Enhanced workflow efficiency


Design


Concept Development

I created conceptual designs to align leadership vision and facilitate cross-functional communication. These designs focused on two core components:

Organization Profile

Study List Page

Connected Navigation

Understanding how users move through the system was crucial. I developed a comprehensive navigation flow ensuring users could efficiently access any part of the system, regardless of their starting point.

Building the System Architecture
Working closely with the product lead, I developed two critical frameworks:

Object Attributes Map

A detailed mapping of attributes that define each object, creating a foundation for Phase 1 implementation. This modular structure allows for future system evolution and enhancement.

Actions Matrix

A comprehensive list of object actions that defined what users could do throughout the system. This framework was essential for prioritizing features and determining access levels, as it captured all potential user privileges across the platform.

Next Steps


The path forward includes continuing user feedback sessions and coordinating change management strategies. We're planning subsequent phases to expand beyond initial priorities while supporting development teams in implementing the concept and strategy.

Lessons Learned

This work represents a significant advancement in clinical research technology. Given the complexity and heavy regulations in clinical research workflows, bringing this project to implementation was a substantial achievement. The experience highlighted the critical importance of stakeholder management and engagement. While team collaboration and communication are essential, securing organizational buy-in proved crucial for project success. The project demonstrates effective cross-functional collaboration and strategic problem-solving in a highly regulated industry.
Next to Seminars Attended