Clinical Research Information eXchange (CRIX) International has entered into a Memorandum of Agreement (MOA) with the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to establish a public-private partnership for a pilot project involving the FIREBIRD application originally developed by the NCI.

CRIX International was set up in December 2006, with initial capital contributions from Pfizer, Amgen, and Novartis, to develop products and services that would facilitate the exchange of electronic information between the various parties involved in clinical research. These include the industry-endorsed CRIX technology platform, which provides a collaborative research environment for drug development.

Under the MOA, CRIX International will manage, and pursue the further development of, the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD), an application designed to enable clinical trial sponsors and the FDA, to manage in a fully secure electronic environment clinical investigator information as required for documentation on the agency’s Form 1572.

Form 1572 is the document whereby clinical investigators provide the trial sponsor with information on their qualifications to conduct a particular study as well as committing to run the proposed study in accordance with the protocol and relevant federal regulations.

According to CRIX International, the pilot project to develop and implement additional requirements for FIREBIRD “will move site initiation and investigator registration away from a paper-based process and closer to a fully electronic process, as well as create a common registry of investigators for 1572 submission and regulatory review”.

Diana McKenzie, vice president of information systems infrastructure at Amgen, said the successful deployment of FIREBIRD could reduce the cycle time associated with investigator registration from eight weeks to “mere months”. Reducing the delays, errors and costs associated with this process “will ease the administrative burden for investigators, allowing them to focus on patients”, she added.

FIREBIRD will be the first service delivered through the CRIX Collaborative Platform to be used by public entities and private industry together, CRIX International noted.