Over the years, clinical trials have benefited significantly from Electronic Data Capture (EDC) systems. In an industry as time-sensitive as clinical research, these innovative systems have proven indispensable to sponsors and CROs.
The research consultants at Study Builders were contracted for a Phase 0 exploratory biomarker study. For their study build and data management, the sponsor originally selected a basic, lower-cost eClinical solution provided by a Medrio competitor. But when they needed more efficiency to meet their timeline and data management needs, the sponsor chose to switch solutions midstream. Medrio’s innovative EDC system allowed them to rapidly deploy without compromising their overall study timeline or exceeding their budget.
This exploratory biomarker study needed an EDC solution they could develop quickly that allowed for sophisticated use of features such as dynamic form design. These constraints demanded that the EDC they chose be seamless, efficient, and easy to use. The short timelines of hypothesis-generating studies are incompatible with EDC solutions whose implementation and functionality require extensive time and effort from data managers. The head of clinical operations at the sponsor company recognized that the study required a straightforward, no-nonsense approach to EDC, and was depending on the Medrio competitor to offer high quality and a robust feature-functionality.
The sponsor quickly realized that the EDC solution they initially selected was not the right match for the study. In order to get the job done quickly and efficiently, Study Builders required more flexibility in the study build process. They needed:
Without these capabilities and resources, they couldn’t reasonably expect to meet the timelines of the study. Having already invested approximately a month of activity into the study build process, they now faced a critical decision: continue with the prospect of launching a sub-optimal system, or risk switching in mid-development, leaving a short time frame for system completion. They decided to take the risk and start again with a new provider. In order to recoup the time they’d already invested, it was more important than ever that they find a solution offering top-tier efficiency and user-friendliness.
The decision to dismiss the original EDC was a bold one, and the sponsor didn’t take it lightly. Study Builders had already completed the majority of the study build, and as the sponsor began evaluating alternative EDC vendors, they were fully cognizant of the significant timeline concerns that starting over could create. Some of the staff at the sponsor company had both used and evaluated Medrio at previous companies earlier in their careers and had been impressed by the feature-functionality and cost-efficiency of the software. They had found that Medrio, while intuitive and effective across all study phases, was a particularly good fit for early-phase studies, and could be deployed effectively in tight timeframes. For this reason, the sponsor had a high degree of confidence in selecting Medrio to rescue the study build.
It didn’t take long for the team to feel the impact of the switch. Medrio outperformed the original EDC in these ways:
These features enabled the speed, efficiency, and flexibility that the study demanded. Equipped with a user-friendly and highly functional EDC system, the research team was able to mitigate any potential negative impact to the study timeline that the EDC switch had threatened to create.
These advantages, combined with the general user-friendliness of Medrio’s interface and the absence of any required programming during study build, led to a rare but game-changing achievement: Study Builders was able to complete the initial study build in a mere three days. Considering the breadth of the workflow involved – the data managers were tasked with creating 28 unique forms, four visits, and over 200 edit checks – this was no small feat.
“Typically, a comparable study takes about three weeks to build,” said Temple Herlong, Managing Member at Study Builders. “We definitely felt a big difference with Medrio. The process was much more efficient.”
Providing efficiency and flexibility in study build at an affordable rate are central components of Medrio’s mission as an EDC company. But Medrio, of course, is just one player in this story. The adept risk management by the study sponsor, the EDC savvy of Study Builders, and the simplicity, efficiency, and flexibility of Medrio all played crucial roles in keeping the study on track.
Dealing with variables and obstacles is part of the nature of clinical research. How sponsors react in these situations can be a major factor in deciding their success or failure. “In clinical research, it’s natural for sponsors to find themselves facing some tough decisions,” commented Mike Novotny, Founder of Medrio. “If an eClinical solution isn’t providing the necessary speed and efficiency, which are so important in this industry, sometimes it’s necessary to take a risk and switch to a proven innovator capable of meeting those needs. The research team that took on this study handled this situation expertly.”
Study Builders is a California-based clinical research-focused consulting company composed of professionals with years of experience in building and managing clinical trials. We are a small company by design, with low overhead so that we can remain agile and able to quickly and effectively build solutions that work for our clients. Our team is made up of EDC system designers and developers, SQL, and Access database developers, SAS programmers, data managers, web and mobile applications developers, UI designers, and website designers. Each is an experienced consultant in his or her field and clients are only charged for the consultant work that they need.
At Medrio, we know it takes a global village to achieve a healthier world. Since 2005, we’ve developed a successful ecosystem of visionary people like you who want to change the world- employees, customers, and partners alike.
We’ve supported sponsors, CRO’s, and sites from across the life sciences industry spectrum. With our help, they have secured more than 375 approvals and reached critical breakthroughs. Our expertise spans all therapeutic areas and covers all phases of clinical trials. We aim to deliver the best customer experience possible because your success is our success. For more information, please visit www.medrio.com.