Ahead Of SCDM 2019, Medrio CEO Mike Novotny Discusses How eSource Can Change The Clinical Data Industry

This year’s Society for Clinical Data Management conference (SCDM 2019) is scheduled for September 29 through October 2 in Baltimore, Maryland. 

 

It’s the world’s most important conference in the field of clinical data management, and I’ve been attending for over 20 years—even before I started my own clinical trial software company, Medrio. SCDM focuses on education around the back-end operations of clinical trials (namely building, managing, and cleaning databases)

 

Over the years, I’ve seen the conference—and the clinical research space itself—grow and evolve. But it hasn’t evolved as much as it could have. 

That’s why, for SCDM 2019, I’ll be the Session Chair on the panel for Session 14: Gimmick or Game-Changer? What eSource Really Does to Clinical Trial Costs and Timelines. It’s one of the most crucial changes in the clinical data management world today. 

 

Here’s why:

 

The future of clinical trial data management is eSource and DDC. 

 

In short, eSource, including Direct Data Capture (DDC), has to do with where and how the data is first recorded. 

 

As defined by the FDA, the source is the initial record of a piece of data, and it needs to be maintained and preserved to ensure that collected information is valid. Roughly 20 years ago, all data from patients—blood pressure, prescribed medication, test results—was recorded on paper.

 

There’s still an incredible amount of paper used in clinical trials, including as the source (as opposed to “eSource”). Unfortunately, that makes it difficult to access the potentially transformative data that doctors and researchers need. The result is a deeply inefficient, expensive, and error-prone process for data collection and cleaning.

 

Now, there’s a push to digitize all initial data inputs, and it’s called eSource. 

 

There are several reasons why an electronic source makes the most sense, the first being a reduction in paper waste. But it’s not just about an eco-friendly system. It’s also about a more practical and affordable one. 

 

When the data is recorded on paper, it needs to be physically stored in a binder or box, and then accessed when needed, for example during a process called monitoring, which can be a fourth of the clinical trial budget. It’s a massive expense. 

 

But if the information was digitized from the start, anyone could do the monitoring from anywhere, and source data verification (SDV) can be reduced almost to zero, making the job of monitors much more interesting. It also saves time and money, and improves the reliability of the data. 

 

That’s the why. Here’s the how

 

Direct data capture (or DDC) is a type of eSource, which mainly involves collecting data using a tablet rather than paper. For the rest of the world, that sounds easy enough—nowadays, it’s not uncommon to see servers in restaurants using tablets to take orders, or vendors using them to swipe credit cards. 

 

But in the clinical trial world, change is a bit slower. 

Many people in the industry may have heard the terms eSource and DDC, but that doesn’t necessarily mean they understand the wide-spread benefits—or how to implement them. During SCDM 2019, my panelists and I will be addressing common questions on costs and timelines, as well as relaying real-world examples of the eSource revolution. 

 

For clinical professionals who haven’t yet signed up, it’s an event worth considering

 

SCDM is a great place to explore a shared passion for clinical trial data management with industry peers. 

 

My favorite thing about this conference? Out of the 800 participants, most are hands-on, operational professionals. Unlike events that target executive leadership, the attendees at SCDM are the people who are down in the trenches. They’re compassionate nurses who are looking to learn about clinical trials, or dedicated software developers who want to make data management easier and more transparent. 

There’s a lot of education happening, and it’s all being used to transform the life sciences industry. 

Needless to say, it’s an incredible place to network. There’s a sense of community you won’t find at most other conferences. Even though the seats are filled with people in all different roles, their objective is the same: to break down data management to the basics, so people can use that information to change clinical research for the better. 

At Medrio, our intention is to push the industry forward by streamlining the research process, and SCDM 2019 is one of the best places to spread our message. If I and my fellow panelists can help to push this conversation along, we’ll be one step closer to a world without disease