EDC Build

edc-build

The industry approach to building studies in an EDC system is based on strict functional roles. The primary objective in a trial is to analyze data, not simply collect it. This is not an insignificant point. The industry approach to EDC builds leads to a system that is not always focused on collecting relevant data or relevant queries. A significant amount of effort (programming, validation, data entry, monitoring, and query resolution) gets expended on unnecessary data and related checks. Sometimes, the necessary data and the quality checks that should have been carried out end up getting left out. Innoventz’s approach is to integrate the specification and the build process to yield a system that produces better data.

I’m already using or plan on using an EDC platform. Why do I need Innoventz?

There is nothing inherently “magical” or “effortless” about using an EDC platform. The fundamental rule of data still applies: “Garbage in, garbage out.” To frame our thinking, consider how the field of consumer electronics shows the necessity of proper configuration of any technology to leverage its benefits. Buying a smartphone doesn’t make you any smarter. It merely provides you a platform. The manufacturer passionately promotes the ease of use for the phone. However, there is a difference between ease of use and complexity of configuration. Once properly configured, the phone can be used easily and may indeed make you smarter.

This same principle holds true for EDC platforms. There is a difference between ease of use and complexity of proper configuration. Innoventz consultants are professionals who have been trained on the intricacies of the platform. We have experienced the pros and cons of various configurations. This experience helps you get better data.

An inefficient study build manifests itself in additional effort and cost in site monitoring and biostatistical analysis, as well as an overall increase in overall clinical operations. If you have experienced budget overruns in previous studies, it would be instructive to analyze your study build to determine if that is at least part of the problem. The EDC configuration can set the overall tone for the conduct of the entire trial.

Supported Platforms and Services

Our team specializes in working on Medrio, Mediadata RAVE, and Oracle Clinical. We are able to deliver the following range of services on these and other EDC platforms:

  • Database specification and core configuration development
  • Edit check and design gap analysis
  • Custom Report design
  • User Acceptance testing
  • Data extraction and data set creation
  • Technical liaison between sponsor and EDC company
  • Business process re-engineering

Get started today by contacting Innoventz.

Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.

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13 September 2011

Bringing back new data management standards and processes from SCDM!

12 September 2011

Quyen and Mandy from Innoventz are attending the SCDM conference in Baltimore this week!