Case Study

Why User Experience Is Essential to Success with EDC

Why User Experience Is Essential to Success with EDC

Objectives

  • Initiate study with user-friendly eCRFs  
  • Gain fast fluency in a new EDC platform
  • Customize databases easily

Success with EDC

  • Built study and solved challenges easily
  • Met specific database customization needs
  • Maintained full control over form build and data capture

Results for Aziyo

  • Reduced study build to several days
  • Onboarded new user quickly and seamlessly
  • Able to meet varying data management needs with a single tool

 

Background

Aziyo Biologics conducts clinical trials of innovative medical products across a wide variety of therapeutic areas, including cardiology, orthopedics, wound care, and others. As a busy and diversified sponsor organization, they require a data management solution as flexible as they are. After joining the company ten months ago, Stephanie Beall, Clinical Research Coordinator at Aziyo, found the electronic data capture (EDC) solution in use at the company not only to possess this essential flexibility, but to be an easy-to-use resource ideal for quickly and seamlessly onboarding new users.

Objectives

“We need to be able to customize each database that we open to meet the unique requirements of each therapeutic area of study.” - Stephanie Beall, Clinical Research Coordinator, Aziyo Biologics, Inc.

When Stephanie Beall joined Aziyo, the company had been using Medrio for about four months. Beall, however, was not familiar with Medrio at the time, and her previous experience with eClinical software consisted of a limited solution that did little to reduce reliance on paper-based data capture. “I was eager to try something that didn’t involve the mounds of paper that are typically involved with the execution of a clinical trial,” Beall says. Before diving into her first study at Aziyo - a post-market clinical trial for a viable bone allograft - she would need to get up to speed on Medrio EDC and its more robust feature functionality, in which her colleagues were already fluent. And, given the time-sensitive nature of her work, she would need to do so quickly.

On an organizational level, Aziyo had other requirements as the study progressed. While their work generally falls under the umbrella of regenerative medicine, their purview covers a number of treatments for a wide variety of indications, from allograft tissue products including bone, tendons, skin and placental tissue products to devices for use in a number of cardiovascular indications. As such, one of the most important qualities, for Beall and her team, that an EDC system can possess is the flexibility to meet the disparate needs of the numerous types of studies they conduct, and the ability to be changed easily as needed. “We’ve got such a wide variety of products,” explains Beall. “We need to be able to customize each database that we open to meet the unique requirements of each therapeutic area of study.”

Success With EDC

Beall had access to a variety of resources and granular control over her database.

Beall got to work in Medrio and quickly found the system to be intuitive and easy to use. She was able to build her database using a drag-and-drop interface with no programming required, keeping the processes simple and fast and eliminating the need to hire programming consultants. She used Medrio’s Form Preview feature to check her work after creating new variables, a useful capability for a new user in the process of becoming fluent in EDC. And she had access to a variety of resources that empowered her to either find answers to her questions independently - via how-to articles, best practices, user-submitted tips and tricks, and other resources within the software - or quickly get on the line with a 24/7 support team.

Once she was up to speed and confident in the software, Beall found it easy to customize her database to meet the specific needs of her study. Features like skip logic and conditional formatting options gave her granular control over the content and appearance of her database. She was able to generate new versions of her eCRFs without any carry-over data from previous versions that she would need to manually delete - a challenge she had previously faced with other systems. This flexibility didn’t just lend itself to the varied nature of Aziyo’s research - it added efficiency and fluidity to the experience of using the software. “All of the extra formatting options and functions available in Medrio help me design an eCRF that is clear and user-friendly,” says Beall.

Results for Aziyo

Aziyo is equipped to build studies and onboard new users with speed and efficiency.

From the combination of these factors, Beall and her team yielded benefits that applied both to individual studies and to their organization as a whole. While study build in EDC typically takes several weeks to several months to complete, Beall utilized Medrio’s drag-and-drop, programming-free interface to drastically reduce this timeline: “With Medrio, I can build my study in only a few days,” Beall says. “It’s definitely a big improvement over other systems.” This efficiency, coupled with the ease of database customization and mid-study changes, have equipped Aziyo with a data management resource they can deploy easily and effectively across a wide variety of studies.

On top of this, Aziyo has been able to overcome a common challenge for EDC users: getting new users up to speed on their software quickly and easily. As organizations take on new employees, often putting them to work on studies already in progress, it’s essential that they be able to get those new users fluent in the software without delaying their studies to invest significant time and budget on training. Through the ease of use and ample support resources that Beall found in Medrio, it’s clear that Aziyo has that ability. And with the speed and efficiency they now enjoy - whether it’s in study build, data management, or EDC user onboarding - they’re equipped to accelerate the delivery of their innovative medical products to populations in need.

About Aziyo Biologics

Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015, the company has expanded through acquisitions and strategic partnerships, creating a high-growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular, and other medical specialties. For more information, please visit www.aziyo.com.

About Medrio

Medrio is a leading healthcare technology company providing eClinical solutions including EDC, eSource, and ePRO for clinical research. Founded in 2005, the company's cloud-based software platform and mobile suite of products deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively across drug, device, diagnostic, and animal health trials.  Medrio has extensive experience in all study phases and leads the market in early-phase trials.  The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations.  For more information, please visit www.medrio.com.