1. Electronic Data Capture (EDC)

Electronic Data Capture (EDC) is admittedly a fairly generic sounding term, but in the clinical trials field it actually means something fairly specific: using systems to collect clinical trial data in electronic form as opposed to paper form. This was the first and most important application we were tasked with building. The EDC is a critical component of modern clinical research, streamlining the data collection process and enhancing efficiency, accuracy, and data quality. They help researchers, sponsors, and regulatory authorities manage trial data effectively. As such, one thing was clear from the beginning, this system would be utilized by multiple stakeholders involved in clinical research and trials.

1.1 Role and Process

As a team of initally 2 designers, we individually led the design on different projects. By working closely together, and with our product manager and engineers on the team, we were able to have a very open and collaborative process. I was a very strong advocate for integrating more user research throughout all stages of the design process, resulting in:

• A design requirements document (‘DRD’) that would be created before a project kick-off and shared with the team alongside the existing product requirements doc. The DRD gathered and grouped user research from all available sources and framed the core issues/needs within the overarching jobs-to-be-done for the product. This document helped to bring the team onto the same page, empathize with our users and align on priorities from a user experience perspective.


• Remote usability testing practice with clinical staff that helped us test designs and prototypes more frequently and consistently and allowed the whole team to be involved.

1.2 Understanding Users and User Needs

Understanding the requirements of clinical researchers, data managers, and end-users was foundational. The product and design team conducted thorough research involving a mix of qualitative and quantitative methods, including interviews, surveys, and observing user workflows.

It was essential to grasp the pain points, challenges, and specific needs of each user group. Researchers would prioritize ease of data entry and access, while data managers would focus on data integrity and system integrations. Gathering this comprehensive understanding helped in creating a system that met diverse user needs.

1.3 Conceptualization and Ideation

Once user needs were identified, the conceptualization phase began. This involved brainstorming sessions and collaborative workshops to generate initial concepts and wireframes. Sketches and rough prototypes helped visualize the system's structure and functionalities. While rapid prototypes aided in creating clickable prototypes that allowed for early-stage testing and validation.

1.4 Design System & UI Design

Having in mind that this would be just the first application of many that we were going to be working on, it was obvious that creating a design system early on was going to be very important in order to ensure visual and functional consistency across apps, efficiency, scalability, as well as ease of maintainability and cross-team collaboration.

Creating a user-friendly interface was paramount, as researchers and data managers will spend significant time interacting with the system. Iterative design refinements based on usability testing and feedback sessions were conducted to fine-tune the interface. This involved surveys and phone calls with clinical staff that validated some of our design and product assumptions.

After many iterations and rounds of user testing and phone calls to validate that we were making the right changes, we launched in an internal Beta period to gather more feedback from our staff. Post-launch, I followed up on the phone with many of the staff that had provided initial feedback, and we also launched a feedback widget for users to provide feedback in-product.

1.5 Results

Vial EDC was released for production in January 2023, and has been used to efficiently in multiple trials since. Since release we’ve added more than 20 new functionalities and improvements. Throughout the design and development process, adherence to regulatory standards was paramount. Compliance with regulations such as HIPAA, GDPR, and specific clinical trial guidelines ensured data privacy, security, and integrity.

What I've shown above is just a small fraction of the project. We designed entire systems allowing multiple user roles to enter patient data, edit, manage and interact with the data in many different ways. Conducting training sessions and workshops to familiarize users with the system's functionalities, data entry protocols, and best practices, enabling them to navigate the system confidently. By meticulously following the design process steps and engaging stakeholders at every phase, we managed to build an EDC system that delivers a robust, user-friendly, and compliant platform for conducting clinical trials

2. Site Startup Platform

Building the Site Startup Platform was the next step towards enabling faster and more efficient trials for sponsors. The Site Startup Platform would enable fast and self-service onboarding—entirely digitally for clinical sites. By eliminating long email threads and archaic document transfer & approval processes, we would simplify and accelerate site activation. The cloud-based site startup would enable onboarding for sites in as few as 30 days, as opposed to 90+ days that it normally takes when done manually.

2.1 Problem Statement and Goals

There is a lack of a centralized platform for clinical sites to access and manage all outstanding tasks required to run a trial / study. Sites receive DocuSigns, fillable PDFs, Excel budgets, and requests for documents, all via email. At any given time, sites are dealing with multiple different trial start ups and requests for information, with no visibility into completion status.

The current process involves manual tracking of outstanding tasks across multiple platforms (multiple monday boards, email, eTMF) leading to delays in site activation and sponsor timelines.

The goal is to provide a unified portal to track individual site onboarding progress, and enable sites to view all outstanding tasks required of them.

3. Site Management Platform

In the field of clinical research operations, effective communication and collaboration between sites and Contract Research Organizations (CROs) (Vial) is crucial for the success of a study. This time we were exploring the implementation of a communication and documentation portal to replace email-based transactional communications. The goal is to centralize key study communications, documents, milestones, and metrics, while also providing additional features to enhance collaboration and efficiency.

3.1 Objectives

After rounds of user interviews and conversations with our clinical operations staff regarding their pain points in the process of site management we agreed to tackle these 6 objectives first:

3.2 Solution for a V1

The proposed solution involves the development and implementation of a communication and information portal for sites. The portal will serve as a centralized hub for study-related information and facilitate seamless interactions between sites and Vial.

Key Features:

4. Monitoring Portal (CTMS)

Clinical Research Associates (CRAs) play a pivotal role in clinical trials. They act as liaisons between the sponsor company and the trial sites conducting the study. Their primary responsibilities include Site Monitoring and Data Verification. CRAs currently rely on manual processes/personal todo lists to manage visits, write reports and follow up on action items. By creating a Monitoring Portal that is integrated with the Electronic Data Capture System (that contains patient data), we would enable CRAs to spend a lot less hours on visit preparation and closure, leading to more efficiently conducted monitoring visits.

4.1 Problem Statement

Current CTMS gaps hinder pace and quality of conducting clinical trials. These include:

4.2 Solution

The solution proposed by the design team was an integrated system, allowing CRAs to set up and keep track of monitoring visits, and create all the necessary reports, where they would be able to keep track of what data they need to verify, outstanding action items, follow up items, as well as allow collaboration between users.

Keeping a consistent visual design to the Electronic Data Capture system was crucial in designing the system as users would be expected to switch between the two quite frequently during their visits, so a sense of familiarity with how the system works would be most useful. Another reason for this was to enable the development team to work faster, by reusing elements from other Vial platforms.

The system is currently in development and is expected to be launched in Q1 of 2024.