By Ann Neuer
June 16, 2008 | CRIX International, the not-for-profit organization dedicated to providing a common electronic infrastructure to the clinical research industry, went live on June 12. “We are heavy in the throes of testing and validation,” says Mark Vermette, product manager.
CRIX stands for Clinical Research Information eXchange, and is a neutral organization that grew out of an alliance among the FDA, the National Cancer Institute and industry leaders. It is focused on reducing the IT friction in the research environment and streamlining interactions between sponsors, their business partners and regulatory agencies to bring therapies to patients faster.
“The effort among players has typically been a one-to-one communication strategy, between sponsor and site, or between CRO and sponsor. CRIX is trying to develop a hub-and-spoke arrangement, in which information can be exchanged easily in a highly secure environment that is very competitive in terms of cost,” Vermette explains. Ultimately, the CRIX platform will enable sites to access all of their studies through a single portal, while providing strict management of authorization levels and authentication of electronic signatures.
To get the ball rolling, on June 12 CRIX launched the investigator registry, which is the portion of the user database that includes profiles of medical professionals. Every CRIX user, including each investigator, completes a profile only once. They provide resume-style information such as education, specialties, board certifications, licenses, and professional experience, and over time, a common registry will be built. “Any medical professional can choose to make their profile private, but we’re encouraging them to make their profiles public so we can announce them as available to our sponsor community,” says Vermette.
The next functionality, expected in early fall, will be the processing of FDA’s Statements of Investigator Form 1572. This form will be populated from data held in the investigator registry, the organization registry for practices, and the study registry, which is maintained by sponsors. If medical professionals keep their profiles up-to-date, the system will automatically complete the forms in minutes.
Pfizer, Amgen and Novartis are the founding members, and they provided the initial investment funding to allow CRIX to exist. Deb Bremer, vice president of development and medical informatics at Pfizer, and a member of the CRIX Board of Directors is passionate about the CRIX collaboration and says that Pfizer is seeking two key benefits. “In the current environment, it is extremely important to be as cost-effective as we can be. There is a common-sense factor that there should be a basic infrastructure for submissions to regulatory agencies that can be built in a formatted way that can be used by the entire industry,” Bremer says.
The other reason is more altruistic. If all of the processes are brought together to make safe, effective and affordable medications available to patients sooner, then the work of creating a standards-based industry-wide electronic infrastructure will make a meaningful difference. Bremer comments, “This is what keeps the passion going. It has to be about more than cost savings.”
Pfizer is currently evaluating how fast to move internal operations to make use of the new CRIX capability. By the beginning of 2009, or possibly sooner, the company is expecting to start using the basic CRIX platform. And depending on the success of the investigator registry and the processing of 1572s, the company plans to participate in those functions as well.
Within the first two weeks of operation, Mark Vermette says he looking for a number of users to register on the portal, starting with existing financial supporters, followed by special interest groups. In August, CRIX is scheduled for a follow-up release.
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