The EDC Buyer’s Guide: Practicals

You’ve finished your comparison of cloud-based and on-premise systems, and done the hard work of translating your study protocol into the EDC database. Now it’s time to start capturing data. How do ensure your sites collect data quickly, ensure accuracy, and share that data in a timely fashion?

In this final installment of our EDC Buyer’s Guide (see the previous installment here), we’ll cover a few questions you can ask to ensure you choose a solution that best empowers you to meet the demands of clinical trials today.

 

Is the solution investing in eSource?

eSource brings eClinical technology to the site level, empowering users to capture source data electronically and sync it to EDC with no paper involved. And with the backing of major regulators and industry players who have yielded its benefits, it’s positioned to be the next revolution in data management, monitoring, and more. Be on the lookout for an EDC solution that provides access to the benefits of eSource, either through native offerings or through integration. With this essential resource at your fingertips, you’ll be able to achieve a multitude of efficiencies and enhancements:

  • Accelerate data collection
  • Ensure accuracy by reducing transcription errors and alerting personnel to missing or out-of-range data
  • Share data immediately, reducing the need for monitoring visits

These benefits have a huge impact on trial costs and timelines, allowing you to increase the number of studies you can perform without scaling up headcount.

Even in WiFi dead spots or during internet downtime, the more cutting-edge eSource solutions are still functional. These tools allow you to store data locally and sync data to your EDC when connectivity is restored. Depending on your workflow and study needs, you can sync after every patient, before and after each shift, or anywhere in between.

 

What’s the patient engagement potential?

eSource isn’t the only resource bolstering the functionality of EDC today. ePRO allows subjects to submit information like quality of life data from the comfort of their home or on vacation. This allows you to:

  • Reduce the number of scheduled visits and burden on the subjects’ busy lives
  • Improve patient retention rates
  • Keep recruitment costs under control

As the clinical research industry places more and more value on patient centricity, eClinical solutions offering ePRO help users stay ahead of the curve.

 

How visible is your study’s progress?

Reporting is an often overlooked but essential piece of the EDC puzzle. When reporting on a system with near real-time access (eSource and ePRO make data available within minutes of collection, compared to 2-3 weeks with a paper process), monitors can better track subject health and completion rates. In addition, if source data is captured with eSource, the electronic source can be monitored remotely. This also gives data managers a better sense of trial success metrics and an idea of whether key health metrics are improving.

While reporting is often the last thing to be reviewed in most platform evaluations, we would
recommend starting with the reporting capabilities. After the study goes live, this is where your data managers will be spending most of their time, so an easy-to-use and easy-to-export reporting system will pay dividends over the long term.

A robust, easy-to-use, and well-designed EDC platform is the grease that keeps the data collection engine running smoothly. When considering an EDC platform, make sure to understand what’s available in terms of eSource, ePRO, and reporting. It’s easy to fall into the trap of choosing the least costly platform only to find that it’s causing labor costs to spike because of poor workflow designs.

Looking for more insight into what ideal eClinical technology today looks like? Visit us at www.medrio.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.