American Biometric Trials–A case study on Linical and Viedoc

Biometrics expert Yolanda Johnson explains how Viedoc's electronic data capture (EDC) system has streamlined data management, reduced costs, and saved time for Linical, a global CRO focused on oncology, vaccines, neurology, and infectious diseases.

A 25-year industry veteran from the Research Triangle in Raleigh-Durham, North Carolina, Yolanda Johnson has always worked with data management and biometrics in some capacity. Moving from big pharma to small pharma, project management to oversight management, paper-based data collection to the revolution of EDC, she has earned her role as an expert, and her long-term experience and dynamic perspectives have given her invaluable hands-on insight.

Today, as Director of Biometrics at Linical Americas, Yolanda supports all aspects of data management, statistics and programming, as well as looking for new business and technological opportunities. In order to keep her clinical study skills relevant and updated, she steps in as a data project manager from time to time, which also gives her a chance to explore the systems her staff works with. In an industry that is constantly ‘shape shifting,' this is essential.

“Our field is always changing. Nothing stays the same in clinical research. There are always new guidelines, new systems, new diseases and new epidemics.”

Linical is a global Contract Research Organization that offers a comprehensive range of drug development services from early stage to large-scale, multinational studies. Linical is a global CRO capable of providing a one-stop service for small or large-scale projects, covering all key markets in Asia-Pacific, Europe, and North America.

Their areas of focus include addressing unmet medical needs in oncology, immunology/vaccines, and central nervous system disorders. They also have experience in other therapeutic areas, such as endo-crinology. Linical maintains a close relationship with its clients throughout the study, offering executive leadership and a hands-on approach to ensure study agility and flexibility.

Understanding the impact of electronic data capture (EDC)

Yolanda is perfectly clear about the effects of EDC on biometrics studies. In the beginning of her career, databases were created with hand-written notations and measurements with hand-held rulers. In her team’s work at Linical today, Viedoc's single sign-on, ePRO, RTSM, and Connect features enable direct data capture and keep Linical ahead of the curve. The system is up and running from the very first subject, providing a streamlined data management system that helps to reduce costs and save time.

“You can have the best insight, the best monitors and be the best company, but if you can't get your data out of the database, then your study fails. Period.”

The first time Yolanda learned about Viedoc was four years ago, when she was starting out at Linical. According to Yolanda, the ways Viedoc has changed clinical studies at Linical has been nothing less than “astronomical” and revolutionized how their biometric studies work.

When she first came across Viedoc, it was an EDC system and nothing more. Over the next few years, ePRO and RTSM were added, as well as several other new modules, features, and up-grades, and world-class design, which improved their data understanding, analysis and reports dramatically. The combined features have reduced costs and saved time, and as anyone working with clinical research will know, keeping to a timeline is critical, and cost efficiency is hard to beat.

The strength of Viedoc, she explains, is multifaceted. Project managers and managing directors appreciate the reports, but if you are a programmer, the programing will be your favorite feature. Someone who needs to report metrics or look at aggregated data across several subjects or across the whole study favor the analysis as the best feature. The entirety of the services means that instead of signing on with five different vendors, for example, the Viedoc platform covers a range of needs, and you never have to log in or out of different systems or switch apps.

“I really think this is going to be the way of the future. As we all know, no one wants to be in meetings all day, every day, eight hours a day. In using a system like Viedoc, you can say, okay, we've done all these things, right here, in our one-stop shop. You want streamlined data management, and that's what Viedoc offers.”

What’s more, she explains, you don't have to be a programmer to make it all work for you and you don't have to go through extensive hours of training. Anyone can plug in and play to modify and create, and you do not need an extensive programing background to manage. Further-more, Viedoc has a great eCRF library that enables edit checks, so you know that you're not re-inventing the wheel. You take the elements, the ingredients you like, and you modify them to fit your particular needs, and when you create your eCRF and put all your modules together, you can add special features that make sense to your study and to the display on the end user side. There is always room for creativity driven by a passion for patients’ health and well-being.

If you're looking for single sign on, Yolanda reiterates, this is the tool for you. There are many modules that come within Viedoc. You have a great ePRO system and it works on any device, so there’s no sending out devices, tracking them, bringing them back in and fixing them. 

There is also a RTSM system, randomization, trial and supply management, and Telehealth. There is a fully compliant and complete audit trail with 21 CFR compliant ethics and they have the ISO 27001 certification and meet all the requirements of GDPR law. And lastly, to round it all off, you can get all of this for a fraction of the cost of the biggest systems, and it will all be up and running in about four to six weeks.

“With Viedoc we are starting to grow. We're really trying to push the sponsors because it is just easier than the classic systems. It’s wiser time-wise and financially. Viedoc is a great company too—always there for you—while the bigger box EDC systems need days to respond or send a quote.”