Can Clinical Trials Benefit from Both EDC and CDR Technologies?

posted on March 27th 2014 in Solutions with 0 Comments /

EDC-blogpost

There are times when our clients need to collect and aggregate date from their clinical trials, and also gain meaningful insights from clinical trial data that can help them make better decisions. In these situations we work with our clients to implement an electronic data capture (EDC) and a clinical data repository (CDR) platform.

Our technology platform of choice for EDC is Medidata Rave®, which is the industry leading EDC solution. Rave’s flexible design supports any organization’s clinical processes and unique clinical trial design needs. Rave is built on industry standards, and it is a highly scalable and configurable system.

We recently implemented both Medidata Rave and our elluminate™ CDR platform for a small innovative pharmaceutical company so they could meet the needs of a complex clinical trial program, collect and aggregate their clinical trial data in a cost-effective manner, leverage CDISC standards, and gain insights from their data so they could quickly make clinical decisions.

In particular, the client needed:

  • An EDC with advanced functionality to accommodate their specific needs for a  rare and specialized patient population cost effectively.
  • A platform that can perform advanced analysis and visualization of all their clinical data in real-time during the conduct of the trial. This needed to address the study level, where using multiple vendors created diverse data streams, and the program level, so the client could analyze and visualize clinical data across multiple trials and trend aggregated data for safety signals.
  • A platform to enable multiple functional groups the opportunity to interact with their data for different uses including safety and clinical project management.

The first component was to integrate Rave. We customized its functionality to allow advanced patient registration and cohort assignment. Due to the complex nature of the patient population, enrollment needed to be managed very closely. Coupled with Rave’s ability for customization and our ability to develop custom functions, we were able to effectively support what proved to be a fast-paced trial.

Rave’s Batch uploader/Rave Web Services capabilities were leveraged to:

  • Integrate external data from diverse sources and systems
  • Transfer subject data from the first study to the extension study reducing the need for data entry

A final component was to implement our elluminate platform, to enable data trending and advanced visualization. elluminate seamlessly pulled data out of Rave at automated intervals using Rave Web Services and allowed our client’s team members to visualize data and look for trends. Specifically, we developed dashboards and views to show ECG values automatically plotted for individual patients showing outliers and changes from baseline. Visualizing the data in this manner allowed for quick action from safety personnel.

Implementing both Medidata Rave and our elluminate platform provided the client with the ability to conduct a clinical trial in a highly specialized patient population in a quick and cost-effective manner.

If you are interested in learning more about the use of Medidata Rave and our elluminate platform to manage clinical trials and gain meaningful insights from clinical trial data, please stop by and see us at the upcoming Mediata Symposium 2014–Americas in San Francisco April 23 – 25, 2014. We’d love to learn about your needs, and discuss how we can support your clinical trial data management needs with innovative IT products and platforms.

Could your clinical trials benefit from electronic data capture or clinical data repository technology?

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