Last week, the Clinical Research Information eXchange (CRIX) announced the launch of a common electronic platform on which pharma companies can create open source applications for use in clinical trials.
CRIX is a not-for-profit organization established by pharma companies and technology experts to eliminate the redundant in-house applications that every pharma company must build to run its trials. Rather than keep everything behind closed doors, CRIX members—including Pfizer, Novartis, and Amgen—are pooling data in an effort drop costs and save time.
"Silos exist within pharma companies because the pragmatic requirements to get a submission done and research completed outweigh the pace and ability to implement standards even if they were fully there," said Jim Bland, executive director of CRIX. "At the same time, we are seeing large and small pharma alike making redundant investments."
The first application released is a common repository for investigator information called Firebird. Investigators need only provide their information once in an online portal and the system autopopulates their 1572 forms (investigator statement of credentials) to submit to FDA.
"When we started talking to pharma and life science companies, it became quickly evident that if they are going to exchange documents and data for the purpose of registering investigators for trials, why not build a broader platform that could be used for other business tools such as exchanging contract documents, images, or clinical trial data?" Bland said.
Users of the system have access to an open source digital signature program, a document sharing tool, and the aforementioned investigator registry. The group expects its pharma companies to add systems they have already built onto the platform, sharing the tools with their peers.
"If you look at the pharmaceutical software market right now, the serious components—the clinical trial management and adverse event processing—are 50 percent of the investment in research and all three of those markets are held very closely by three competitors," Bland said.
Time for a Change
While CRIX does not expect Big Pharma to ditch the expensive infrastructure that it has invested in over the years, it is offering a subset of services that can be used with their systems. On the opposite end, start-up biotechs that lack the capital to invest in systems can find value in what CRIX offers.
But what does this mean for clinical trials solution providers such as Oracle or e-Trials?
"I think a number of these companies are going to try to integrate their products with our platform in some way," Bland said. "Clearly what will happen is that we are going to be driving the market in terms of driving innovation and competition. If an organization can subscribe to a CTMS on the CRIX platform for $100 for month and it costs 10 times that to buy Oracle's CTMS, then I think people are going to be asking questions about the value of the proprietary commercial system."
According to Diana McKenzie, VP of information systems infrastructure at Amgen, this is an opportunity for industry to demonstrate its commitment to connecting healthcare from an information technology perspective.
"CRIX is creating a platform that leverages standards that are common to healthcare and to the industry on which applications can be developed that pharma can share, saving time and money," McKenzie told Pharm Exec.
Amgen is specifically piloting the investigator registry and said that this one process literally saves the company from a couple hundred thousand dollars up to a million, depending on the site.
CRIX has formed a number of advisory committees to broaden its reach beyond biopharma. It is reaching out to CROs and academics to understand their needs. In the near future it plans to work on applications for adverse event reporting and is looking at tools for labeling modification.