How Can Electronic Data Capture Support Risk-based Monitoring?

posted on April 10th 2014 in Solutions with 0 Comments /


As clinical trial sponsors are looking to shift from traditional clinical trial monitoring approaches to risk-based monitoring, an electronic data capture (EDC) system is a key component.

An electronic data capture system supports risk-based monitoring by:

  • Dynamic assignment of source data verification
  • Empowering central monitoring of clinical trial data

An EDC system, such as Medidata Rave, can facilitate risk-based monitoring. Rave enables sponsors to implement targeted source data verification (SDV) rather than traditional clinical trial monitoring approaches.

An EDC system supports enhanced clinical trial efficiency and decreased costs by:

  • Eliminate double data entry–the EDC system captures data directly from other systems, such as a CTMS, and by doing so eliminates the need for duplicate entry
  • Efficient data monitoring work flow–Medidata Rave facilitates data monitoring activities in a user friendly manner with status alerts that update to an individual’s icon to indicate new tasks are ready for review. With an EDC system data entry and modification are the responsibility of the site personnel and the clinical research associates
  • Reduced travel and on-site monitoring expenses–The EDC system facilitates remote monitoring, which decreases the need to visit study sites for data monitoring

Some of the enhancements we have worked with sponsors to implement with Medidata Rave include:

  • Email alerts–sponsors can set pre-defined selections that will trigger an e-mail alert as the data is entered into the EDC system
  • Missing data–sponsors are able to more quickly identify missing data through the EDC system. Earlier identification of missing data allows the sponsor to contact to the study site and request the missing data at an earlier point in time
  • Implementation of risk-based monitoring reports within our CDR elluminate™–sponsors have the ability to generate risk-based monitoring reports because of the tight integration between Rave and our CDR elluminate™

An EDC system is must have tool for sponsors to successfully implement a risk-based monitoring strategy for their clinical trials.  Overall, an EDC system improves the quality of the clinical trial as the data is continuously monitored. An EDC system also enhances clinical trial operations by capturing data directly from a CTMS system and other data sources and eliminating the need for duplicate entry, helping manage clinical data monitoring workflow, and shifting data monitoring to a central location and thus reducing travel expenses for on-site monitoring.

At eClinical Solutions our team has helped many life sciences companies implement and enhance Medidata Rave as an EDC so they can realize all of the benefits of this powerful platform, and we can help you too.

If you are interested in learning more about the use of Medidata Rave to support your transition to risk-based monitoring, 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.

Join the conversation! Can electronic data capture (EDC) support your risk-based clinical trial monitoring efforts?

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