Look for Flexibility In an EDC System

Sites should look for flexibility when shopping for electronic data capture (EDC) systems and should be aware of the increasing potential for integrating information from electronic medical records (EMRs), according to one prominent vendor.

The changing nature of clinical trials calls for such flexibility, said Dennis Constantinou, senior industry director of life sciences strategy and marketing for Oracle, and Mychelle Mowry, the company’s vice president of global health industries.

The complex demands imposed by pharmacogenomics, changing regulatory requirements and the growing number of international trials are some of the factors driving this need. “The system has to be very flexible — the end users have to be able to modify protocols and fit their research requirements,” said Mowry.

Clinical trials in which patients move from site to site, or with small numbers of enrollees due to protocol requirements, pose a particular headache for sites seeking to implement EDC, Constantinou noted.

Sponsors Turn Attention to Investigators

A more fundamental problem has been that sponsors and contract research organizations have designed EDC systems “from the vantage point of their requirements,” Constantinou said.

“Now that EDC is reaching the tipping point in the industry, we are seeing that sponsors are paying more attention to investigators and their needs to increase compliance with EDC and spread the adoption of EDC.”

Sites, in turn, are being more assertive about telling sponsors what they need in their EDC systems, he added.

A new Oracle system is designed to address some of these problems. The company Sept. 19 introduced its Remote Data Capture Onsite EDC system, which is targeted mainly at sites.

It is primarily a front-end system (that is, the part of a computer program that a user sees and interacts with directly) and is meant to be integrated with Oracle’s clinical data management system, Constantinou said. The company says its new product makes it easier to enter data into case report forms (CRFs), and that the system includes electronic messaging between users.

At present, staff involved in a clinical trial are often put in the position of having to enter the same data twice, once in the electronic CRF and once in the EMR, Constantinou said. “The whole idea is to streamline the process, reduce redundancies and increase the quality of the information.”

That day may be coming closer. “There is no reason we can’t have an interchange between EDC and electronic medical records. In a recent study, they showed they were able to capture 53 percent of the data needed in the CRF from the electronic medical record…. And that was only the laboratory data,” Mowry said. — Martin Gidron