The honor system didn’t work, it seems.

Last week, the Clinical Data Interchange Standards Organization (CDISC) officially certified two vendors (as far as we can tell) as compliant with the operational data model (ODM). ClinPhone and XClinical are both European clinical trial technological concerns that have taken pains to ensure their technology adheres to the nuances of the CDISC standards. They’ll get the right to display a new CDISC logo. There is no comparable program for sponsors of clinical trials yet.

The certification has been in the works for at least a year, with the standards organization helping selected technology firms to assess their ability to import and export trial data according to the ODM protocol.

But the certification remains a watershed event, heralding an era in which cumbersome, migraine-worthy integration projects might not be necessary or painful. If the industry truly accepts standards, the Gartner consultancy has calculated, significant savings across a portfolio of trials would be feasible. So CDISC certification is certain to intensify a behind-the-scenes scramble as other software firms try to win the same blessing from CDISC.

Quoting Kush

The effort earned a rare public endorsement by Becky Kush, the CDISC president and standards evangelist. She has previously been studiously neutral on the relative merits of the organizations supporting her organization with human volunteers and dollars. But in this case, she made an exception.

“We are very excited to kick-off the new CDISC certification program and would like to thank ClinPhone for all of their hard work to become one of our first Certified Partners,” Kush said in the press release.

Marketing Edge

ClinPhone was equally pleased. “The entire industry was saying they were CDISC-certified based on financially supporting CDISC,” says James Young Kim, associate director of marketing at ClinPhone.

He hastened to add that financial support was not equivalent to actually having software that can import and export data in CDISC formats. But some companies may have benefited from confusion in the marketplace around that issue. Kim sees that confusion going away. “This will provide us that edge,” says Kim. “It gives ClinPhone EDC products the highest stamp of approval in terms of ODM. That is a true differentiator.”

Will Partners Align?

Another ClinPhone executive, Nick Richards, says that the company hopes a host of partners—laboratories, drug safety firms, even optical character scanning companies—will also embrace the standard and create further efficiencies. Richards is philosophical about how long the CDISC-certification will be a rare and novel imprimatur. “This program is going to start driving the pace of developing tools much, much faster,” says Richards, senior VP of product management at ClinPhone.

Richards says that there was confusion in the marketplace about technology vendors offering financial or human resources in support of CDISC—and having the software actually hew to the letter of the standard.

DataLabs Technology

The process of certification lasted perhaps two years, the ClinPhone executives say. Both joined ClinPhone as part of its acquisition of DataLabs, an electronic data capture (EDC) firm. The deal was announced last fall, shortly after ClinPhone sold shares to the public in London.

That transaction now looks even more pivotal as ClinPhone seeks to leverage a happy customer base in interactive voice response (IVR) and clinical trial management by offering EDC, too.

Richards isn’t resting on the company laurels. He says the certification process itself will help propel data standards, as CDISC and other companies being evaluated continue to sort out what adherence to the standard really means.

Native Support

Other technology companies, Richards predicts, will follow in ClinPhone’s footsteps, especially if they have always supported CDISC natively, without extensive use of proprietary data structures.

On a practical level, Richards notes his company has always used the ubiquitous PDF format, but it can now archive clinical trial data in native CDISC formats, eliminating the potential need to find an application to view such data in the year 2023. Certification of some applications, he says “is going to make people more comfortable and less dependent on proprietary files and formats.”

A Culture of Resistance

Some of the most pressing questions about standards have nothing to do with the quality of tools to implement them, and relate more to the mindset of those using the software in the industry. It will be interesting to see if any sponsors of clinical trials care about the CDISC stamp of approval enough to shift technology purchasing.

With many impregnable silo-like therapeutic areas in pharma, not to mention entire companies with their own quirky data standards, some of the impediments to standards adoption remain well outside the purview of CDISC or technology vendors. The industry’s complex and status-quo-oriented culture, in short, remains a more vexing issue than the merits of the most well-designed tools.