Revolutionizing Clinical Trial Management with AI
Revolutionizing Clinical Trial Management with AI
Revolutionizing Clinical Trial Management with AI
Role
Role
UX Design Lead
Industry
Industry
Medical
Project Type
Project Type
Rapid Protoyping
Tools
Tools
Figma, Figjam
Duration
Duration
2 Weeks
Overview
I led the design of the Clinical Trial Management Tool (CTMT) Gen AI MVP, a transformative solution aimed at enhancing clinical data review and streamlining external data reconciliation processes. With only two weeks to design, I navigated unfamiliar territory in clinical trial management, engaging with stakeholders and leveraging rapid wireframing to produce impactful solutions.
The project’s primary goals were to automate the creation of specification documents from approved sources and improve trial data accuracy and efficiency. Through daily reviews and close collaboration, I iterated on designs quickly, ensuring stakeholder alignment and delivering a product that addressed core user pain points while adhering to tight deadlines.
I led the design of the Clinical Trial Management Tool (CTMT) Gen AI MVP, a transformative solution aimed at enhancing clinical data review and streamlining external data reconciliation processes. With only two weeks to design, I navigated unfamiliar territory in clinical trial management, engaging with stakeholders and leveraging rapid wireframing to produce impactful solutions.
The project’s primary goals were to automate the creation of specification documents from approved sources and improve trial data accuracy and efficiency. Through daily reviews and close collaboration, I iterated on designs quickly, ensuring stakeholder alignment and delivering a product that addressed core user pain points while adhering to tight deadlines.
I led the design of the Clinical Trial Management Tool (CTMT) Gen AI MVP, a transformative solution aimed at enhancing clinical data review and streamlining external data reconciliation processes. With only two weeks to design, I navigated unfamiliar territory in clinical trial management, engaging with stakeholders and leveraging rapid wireframing to produce impactful solutions.
The project’s primary goals were to automate the creation of specification documents from approved sources and improve trial data accuracy and efficiency. Through daily reviews and close collaboration, I iterated on designs quickly, ensuring stakeholder alignment and delivering a product that addressed core user pain points while adhering to tight deadlines.
Introduction
In the fast-paced clinical research world, efficiency and accuracy are paramount in managing trial data and ensuring compliance with regulatory requirements. The Clinical Trial Management Tool (CTMT) Gen AI MVP is a groundbreaking solution that revolutionizes the clinical data review process and streamlines external data reconciliation.
This case study delves into my rapid wireframing journey of creating the CTMT Gen AI MVP within a tight two-week timeline.
In the fast-paced clinical research world, efficiency and accuracy are paramount in managing trial data and ensuring compliance with regulatory requirements. The Clinical Trial Management Tool (CTMT) Gen AI MVP is a groundbreaking solution that revolutionizes the clinical data review process and streamlines external data reconciliation.
This case study delves into my rapid wireframing journey of creating the CTMT Gen AI MVP within a tight two-week timeline.
In the fast-paced clinical research world, efficiency and accuracy are paramount in managing trial data and ensuring compliance with regulatory requirements. The Clinical Trial Management Tool (CTMT) Gen AI MVP is a groundbreaking solution that revolutionizes the clinical data review process and streamlines external data reconciliation.
This case study delves into my rapid wireframing journey of creating the CTMT Gen AI MVP within a tight two-week timeline.
Please note that the client's name has been redacted and every visual has undergone a significant revision to protect the Client's intellectual property.
Project Objectives
The CTMT Gen AI MVP's primary objectives were twofold. The MVP aimed to generate specification documents from approved source documents, streamlining documentation workflows and ensuring compliance with regulatory standards.
The CTMT Gen AI MVP's primary objectives were twofold. The MVP aimed to generate specification documents from approved source documents, streamlining documentation workflows and ensuring compliance with regulatory standards.
Improving the clinical data review process
Improving the clinical data review process
Prioritizing External Data Reconciliation
Prioritizing External Data Reconciliation
The Challenge
The Challenge
The project presented a formidable challenge for me with a compressed timeline of just two weeks. I had limited knowledge of clinical trial management and data reconciliation processes. However, I embraced the challenge and was determined to deliver a solution that exceeded expectations.
The project presented a formidable challenge for me with a compressed timeline of just two weeks. I had limited knowledge of clinical trial management and data reconciliation processes. However, I embraced the challenge and was determined to deliver a solution that exceeded expectations.
The Solution
The Solution
Iterative Design and Stakeholder Engagement:
Iterative Design and Stakeholder Engagement:
Despite the tight timeline, I prioritized frequent communication and collaboration with stakeholders to gather feedback and iterate on designs iteratively. Daily design reviews provided opportunities for stakeholders to provide input and validate design decisions, ensuring alignment with project goals and user needs.
Despite the tight timeline, I prioritized frequent communication and collaboration with stakeholders to gather feedback and iterate on designs iteratively. Daily design reviews provided opportunities for stakeholders to provide input and validate design decisions, ensuring alignment with project goals and user needs.
Please note that the client's name has been redacted and every visual has undergone a significant revision to protect the Client's intellectual property.
Research
RESEARCH
The Big Idea
The Big Idea
The project kicked off with a series of intensive working sessions to define the future state user journey, requirements, and user stories. Despite the steep learning curve, I collaborated closely with stakeholders to gather requirements and clarify the project scope. Rapid wireframing sessions began, focusing on creating low-mid fidelity wireframes to visualize each page required for the MVP.
The project kicked off with a series of intensive working sessions to define the future state user journey, requirements, and user stories. Despite the steep learning curve, I collaborated closely with stakeholders to gather requirements and clarify the project scope. Rapid wireframing sessions began, focusing on creating low-mid fidelity wireframes to visualize each page required for the MVP.
Week 1
Working sessions were dedicated to defining user journeys, requirements, and user stories. A design kickoff marked the midweek milestone, followed by design reviews to refine and iterate on the wireframes.
Working sessions were dedicated to defining user journeys, requirements, and user stories. A design kickoff marked the midweek milestone, followed by design reviews to refine and iterate on the wireframes.
Week 2
I finalized designs and handed them off to developers for build. Meanwhile, I facilitated a rapid prototype for a stakeholder demo, providing stakeholders with a tangible preview of the MVP before development was complete.
I finalized designs and handed them off to developers for build. Meanwhile, I facilitated a rapid prototype for a stakeholder demo, providing stakeholders with a tangible preview of the MVP before development was complete.
Through the client workshops, I created a rough site map/features list of the application aided by an understanding of the workflow of a Data manager.
*All other research insights cannot be shown due to confidentiality reasons.
Through the client workshops, I created a rough site map/features list of the application aided by an understanding of the workflow of a Data manager.
*All other research insights cannot be shown due to confidentiality reasons.
RESEARCH
Getting to Know Our Primary User
Getting to Know Our Primary User
The primary user of the CTMT Gen AI MVP is the data manager, who plays a pivotal role in managing assigned trials, reviewing patient information, and resolving discrepancies. With the CTMT, data managers can efficiently navigate trial data, take action on discrepancies, and ensure data integrity and compliance.
The primary user of the CTMT Gen AI MVP is the data manager, who plays a pivotal role in managing assigned trials, reviewing patient information, and resolving discrepancies. With the CTMT, data managers can efficiently navigate trial data, take action on discrepancies, and ensure data integrity and compliance.
User Frustrations
What do our users need?
A centralized dashboard to monitor the status and key metrics of all ongoing trials.
AI-driven recommendations to quickly identify and resolve discrepancies.
Real-time data updates and alerts for critical issues.
Intuitive UI for efficient data management.
Collaboration tools to communicate with team members and stakeholders effectively.
A centralized dashboard to monitor the status and key metrics of all ongoing trials.
AI-driven recommendations to quickly identify and resolve discrepancies.
Real-time data updates and alerts for critical issues.
Intuitive UI for efficient data management.
Collaboration tools to communicate with team members and stakeholders effectively.
What goals do they have?
Ensure data integrity and accuracy across all clinical trials.
Efficiently manage and resolve discrepancies to maintain trial compliance and timelines.
Streamline data review and reconciliation processes to improve overall efficiency.
Leverage AI-driven tools to enhance decision-making and reduce manual workload.
Ensure data integrity and accuracy across all clinical trials.
Efficiently manage and resolve discrepancies to maintain trial compliance and timelines.
Streamline data review and reconciliation processes to improve overall efficiency.
Leverage AI-driven tools to enhance decision-making and reduce manual workload.
RESEARCH
Core Capabilities
Core Capabilities
My user-centered research revealed critical insights, such as the need for real-time updates, efficient discrepancy management, and streamlined communication tools.
My user-centered research revealed critical insights, such as the need for real-time updates, efficient discrepancy management, and streamlined communication tools.
To address the needs of data managers and streamline the clinical trial management process, CTMT includes the following key features:
To address the needs of data managers and streamline the clinical trial management process, CTMT includes the following key features:
Centralized Dashboard
Provides an overview of all assigned clinical trials, listing studies with key statistics and real-time updates.
Provides an overview of all assigned clinical trials, listing studies with key statistics and real-time updates.
Study Details Page
Offers a comprehensive view of individual trials with visual metrics and a detailed table of patient data.
Offers a comprehensive view of individual trials with visual metrics and a detailed table of patient data.
Patient Discrepancies Management
Features AI-driven recommendations, options to review and select actions, tools for internal or site submissions, and query closure functionality.
Features AI-driven recommendations, options to review and select actions, tools for internal or site submissions, and query closure functionality.
Discrepancy Resolution Tools
Categorizes discrepancies, analyzes historical data, and validates data integrity.
Categorizes discrepancies, analyzes historical data, and validates data integrity.
Communication Tools
Integrates messaging for team communication, templates for requests, and notifications for updates.
Integrates messaging for team communication, templates for requests, and notifications for updates.
Data Visualization and Reporting
Offers customizable reports, visualization tools, and exportable data for regulatory submissions.
Offers customizable reports, visualization tools, and exportable data for regulatory submissions.
Bringing Ideas to Life
Bringing ideas to life
Low to Mid-fidelity Wireframes
Low to Mid-fidelity Wireframes
On the first day of the design phase, I started by creating low-fidelity wireframes that consisted of content blocks. These content blocks were crucial for confirming the features I would be designing during the design review sessions with stakeholders. This step was essential as part of my design thinking process, ensuring that each content block had a clear purpose and was aligned with our initial discussions.
When the content was confirmed on the low-fi wireframes, I moved on to creating mid-fidelity wireframes. This phase allowed me to delve deeper into the actual visuals and explore different information hierarchies. During this stage, I prioritized taking extensive notes during review sessions. For each page, I ensured that I captured the user goal, the page content list, comments and feedback from stakeholders, and any missing content.
On the first day of the design phase, I started by creating low-fidelity wireframes that consisted of content blocks. These content blocks were crucial for confirming the features I would be designing during the design review sessions with stakeholders. This step was essential as part of my design thinking process, ensuring that each content block had a clear purpose and was aligned with our initial discussions.
When the content was confirmed on the low-fi wireframes, I moved on to creating mid-fidelity wireframes. This phase allowed me to delve deeper into the actual visuals and explore different information hierarchies. During this stage, I prioritized taking extensive notes during review sessions. For each page, I ensured that I captured the user goal, the page content list, comments and feedback from stakeholders, and any missing content.
By documenting the rationale behind each design decision and linking it to our design thinking discussions, I streamlined the approval process with both the development team and the client. This approach was especially important given the complexity of the Clinical Trial Management Tool. By transparently linking design decisions to past discussions, I was able to build and maintain trust with stakeholders, ensuring a smooth and collaborative design process.
By documenting the rationale behind each design decision and linking it to our design thinking discussions, I streamlined the approval process with both the development team and the client. This approach was especially important given the complexity of the Clinical Trial Management Tool. By transparently linking design decisions to past discussions, I was able to build and maintain trust with stakeholders, ensuring a smooth and collaborative design process.
Bringing ideas to life
Finalizing Designs and Prototype Development
Finalizing Designs and Prototype Development
After incorporating feedback, I finalized the high-fidelity wireframes, which included detailed content audits and user goals for each page. These wireframes were then handed off to the development team for build. I also developed a rapid prototype for a stakeholder demo to showcase the envisioned tool and gather final feedback before the build was completed.
After incorporating feedback, I finalized the high-fidelity wireframes, which included detailed content audits and user goals for each page. These wireframes were then handed off to the development team for build. I also developed a rapid prototype for a stakeholder demo to showcase the envisioned tool and gather final feedback before the build was completed.
Bringing ideas to life
Design Sytem
Design Sytem
Throughout this project, I implemented a comprehensive design system. This design system ensured consistency across all components and pages of the Clinical Trial Management Tool (CTMT), promoting a cohesive user experience and facilitating efficient design and development processes. By establishing clear design guidelines, reusable components, and standardized patterns, the design system contributed to the overall success of the project, enabling rapid iteration, easier maintenance, and scalability of the CTMT.
Throughout this project, I implemented a comprehensive design system. This design system ensured consistency across all components and pages of the Clinical Trial Management Tool (CTMT), promoting a cohesive user experience and facilitating efficient design and development processes. By establishing clear design guidelines, reusable components, and standardized patterns, the design system contributed to the overall success of the project, enabling rapid iteration, easier maintenance, and scalability of the CTMT.
Overcoming Stakeholder Challenge
Overcoming Stakeholder Challenge
During the design process for the discrepancies detail page, I encountered a significant challenge with the stakeholders that I am particularly proud of overcoming. The page allows a data manager to take nine different actions on a query. The stakeholders mentioned that users wanted to see all action buttons at a glance. However, this requirement posed a problem from a UX design perspective.
Having nine primary buttons displayed simultaneously creates a cluttered and overwhelming interface, which goes against several UX design principles; visual clarity, Hierarchy and Emphasis, Usabilty, etc.
During my conversations with the stakeholders, I asked them to identify the most important action button, but they were unable to pinpoint a single one. Understanding their needs, I proposed an alternative solution: a primary action button with a dropdown menu that would house the remaining actions.
During the design process for the discrepancies detail page, I encountered a significant challenge with the stakeholders that I am particularly proud of overcoming. The page allows a data manager to take nine different actions on a query. The stakeholders mentioned that users wanted to see all action buttons at a glance. However, this requirement posed a problem from a UX design perspective.
Having nine primary buttons displayed simultaneously creates a cluttered and overwhelming interface, which goes against several UX design principles; visual clarity, Hierarchy and Emphasis, Usabilty, etc.
During my conversations with the stakeholders, I asked them to identify the most important action button, but they were unable to pinpoint a single one. Understanding their needs, I proposed an alternative solution: a primary action button with a dropdown menu that would house the remaining actions.
This solution addressed several key points:
Maintains Visual Clarity and Hierarchy: The interface remains clean and uncluttered, making it easier for users to navigate.
Enhances Usability: Users can quickly identify and perform the primary action without being overwhelmed by too many choices.
Ensures Consistency: The dropdown menu approach aligns with common design patterns, making the interface intuitive for users.
This solution addressed several key points:
Maintains Visual Clarity and Hierarchy: The interface remains clean and uncluttered, making it easier for users to navigate.
Enhances Usability: Users can quickly identify and perform the primary action without being overwhelmed by too many choices.
Ensures Consistency: The dropdown menu approach aligns with common design patterns, making the interface intuitive for users.
The Outcome
Through extensive research, iterative design, and user testing, the CTMT emerged as a game-changer in the clinical trial landscape. Key features such as intelligent discrepancy detection, automated resolution recommendations, and real-time analytics enable trial managers to proactively identify and address issues, optimize processes, and drive trial success.
Through extensive research, iterative design, and user testing, the CTMT emerged as a game-changer in the clinical trial landscape. Key features such as intelligent discrepancy detection, automated resolution recommendations, and real-time analytics enable trial managers to proactively identify and address issues, optimize processes, and drive trial success.
Highlights
Highlights
User Impact: Through the CTMT Gen AI MVP, data managers are empowered to efficiently navigate trial data, take action on discrepancies, and ensure data integrity and compliance.
Future Scope: As the CTMT continues to evolve and adapt to the changing needs of clinical research, its potential for growth and impact is limitless. Future iterations may include predictive analytics, virtual collaboration tools, and integration with emerging technologies to further enhance trial efficiency, innovation, and accessibility.
Learning Curve: Through this project, I honed my skills in user research, interaction design, and prototyping, gaining valuable insights into the unique challenges and opportunities in healthcare technology. I learned the importance of empathy, collaboration, and iteration in creating meaningful solutions that make a difference in people's lives.
In just two weeks, the CTMT Gen AI MVP emerged as a testament to my ability to thrive under pressure, embrace ambiguity, and deliver innovative solutions in record time. Moving forward, the project serves as a milestone in my journey as a UX designer, fueling my passion for solving complex problems and making a meaningful impact in healthcare and beyond.
User Impact: Through the CTMT Gen AI MVP, data managers are empowered to efficiently navigate trial data, take action on discrepancies, and ensure data integrity and compliance.
Future Scope: As the CTMT continues to evolve and adapt to the changing needs of clinical research, its potential for growth and impact is limitless. Future iterations may include predictive analytics, virtual collaboration tools, and integration with emerging technologies to further enhance trial efficiency, innovation, and accessibility.
Learning Curve: Through this project, I honed my skills in user research, interaction design, and prototyping, gaining valuable insights into the unique challenges and opportunities in healthcare technology. I learned the importance of empathy, collaboration, and iteration in creating meaningful solutions that make a difference in people's lives.
In just two weeks, the CTMT Gen AI MVP emerged as a testament to my ability to thrive under pressure, embrace ambiguity, and deliver innovative solutions in record time. Moving forward, the project serves as a milestone in my journey as a UX designer, fueling my passion for solving complex problems and making a meaningful impact in healthcare and beyond.