CRIX is Operating and Launching FIREBIRD Pilot

By Ann Neuer

March 2, 2009 | Several years into the process, CRIX International, the neutral not-for-profit Clinical Research Information eXchange, is moving from start-up phase into operational mode. CRIX is actively working toward getting its much talked about collaborative platform for clinical research stakeholders up and running, and is establishing timetables for key deliverables in 2009.

Interim Executive Director George Rathbun says that once operational, the collaborative platform will enable IT service providers to offer functionalities to members of the CRIX community that will expedite how clinical research is conducted. Members, both public and private, will be able to register to use the platform, receive identity assurance certificates, sign and upload documents, and create workspaces for teams of registered users wanting to share and exchange data.

There are several deliverables on tap to bring the platform alive. One is the high profile FIREBIRD pilot. FIREBIRD—an acronym for Federal Investigator Registry of Biomedical Information Research Data—is an application designed to enable sponsors of clinical trials, the National Cancer Institute (NCI), and the Food and Drug Administration (FDA) to manage clinical investigator information required for documentation on Statement of Investigator form 1572, in a fully secure, electronic environment.

George Rathbun

To fulfill the Memorandum of Agreement, the FIREBIRD initiative is focusing on fast and accurate electronic population of the 1572 form enabled by a common registry of investigators. Within the industry, this is a process that continues to be paper-based, inefficient, and ripe for improvement. The intent of FIREBIRD is to eventually expand beyond the 1572 capability to include pre-population of documents and secure document exchange of various study initiation forms.

Amgen, one of the founding members of CRIX, has developed a business case analysis, documenting the value of using electronic, pre-populated 1572s. “We broke down the site initiation process into concrete steps, and created models based on a small, medium, and large study. We looked at how much time and resources it was taking to initiate each step across the 1000 sites participating in all non-CRO managed studies at Amgen in 2007. The range of savings would fall between $200,000 and $400,000, depending on whether only the 1572 or the full site initiation package were automated through CRIX," says Diana McKenzie, Vice President of Information Systems at Amgen, and a CRIX board member.

In addition to FIREBIRD, McKenzie says there are two significant process improvement opportunities for CRIX, both rooted in the organization’s efforts to create a single portal as a point of access. One is aimed at investigators who will be able to use a single portal to access all of their clinical trials. “Typically, we have driven our investigators to way too many interfaces and tools to do their job. If we make it easier for the investigators to participate in our clinical studies, they have more time to provide quality care to the patients enrolled in our studies,” McKenzie comments. She adds that the single portal also creates opportunities for internal business partners to set up a collaboration space at an address on the CRIX portal where members of the team can share a calendar, and post presentations and meeting minutes.

With CRIX moving forward, the association currently has 300 associate members, which is a free membership, and a handful of full members. CRIX is also seeking vendor partners. The organization’s next deliverable, secure notification of adverse events via the platform, is expected in second or third quarter this year.