Trends and Predictions
“In the past, there was a lot of work done with handheld diaries for patients. And for some studies, that still makes sense, but for others, leveraging existing electronic data capture tools can be a more cost-effective solution,” explained Susan Bornstein, executive vp of eClinical Solutions. The company has developed its own clinical data repository offering, which is designed to enable clinical trial sponsors to keep all data from a trial housed together utilizing the industry standard—Clinical Data Interchange Standards Consortium (CDISC) guidelines.
According to Bornstein, the repository “makes a difference because companies are moving out of the paper world into an electronic world where data is available in almost real time, allowing for proactive data management.”
eClinical Solutions partners with companies to help them standardize their data to meet CDISC guidelines and also comply with Title 21 CFR Part 11, which governs how electronic systems can be used in clinical trials.
In order to meet FDA guidelines for clinical trial data collection, web-based EDC technologies have to be transparent, not proprietary. “One of the key challenges that eClinical technologies should try to address is bringing greater transparency and efficiency across the clinical trial process, for example, by enhancing connectivity and removing silos among the various clinical constituencies,” noted Ashwin Mundra, director of strategic initiatives for Medidata Solutions.
According to Mundra, clinical constituencies include not just the clinical department but also finance, data management, trial management, and trial sites. “One of the main goals of pharma is to remove these silos to help enhance and streamline clinical processes and solve problems that are common to all these departments, not just data management.”
Baumann agreed that transparency in EDC systems is essential. “The way I see this technology moving in the next five years is toward a lighter-weight approach. I really think that open source is one of the primary drivers of the trend. What electronic data capture systems provide today is really centered on the quality of data, the speed at which data can be collected, and the transparency that the system provides the progress of the clinical trial.”