Can a large pharma build a clinical data reporting system that employees will actually clamor to use? Wait. Back up. What is the ultimate objective for any system for clinical trial data? Is it to make a dramatic investment in something new (software) that embalms something old (a sea of paper)? Or is it to identify and act upon trends that were previously invisible?

That question was not, technically, on the agenda at last week’s Premier Forum on Clinical Trial Technology and Data Management. But it was at the core of a presentation by a major pharma. The Forum was sponsored by the Center for Business Intelligence (CBI). The meeting was a granular, in-depth session on a wide spectrum of clinical trial technologies and strategies.

For some companies, it seems, there is a clear and substantive objective to clinical trial technology investment. The goal: gaining visibility across the clinical data panorama and making decisions more intelligently. In other words, can a thousand planning spreadsheets be slowly dragged to the trash?

imageSanofi-Aventis, even after a few mergers, has been able to keep its eye on extremely practical technology goals and appears to be achieving them. Sanofi-Aventis’s Sandy Ricciardi, director of clinical trial management reporting, briefed the CBI Forum and described one of the clearest long-term visions for where a large company should be headed.

Sanofi-Aventis sought to combine all of its major data streams. It needed a reporting tool to be accessed via the company intranet. But to get the reports right, it needed a data warehouse (from Informatica, as it turns out). The company realized it would have no choice but to build what it needed internally. And it understood that data standards would be crucial.

At a time when many companies are wrestling with the real-world headaches of data standards, Sanofi is moving beyond the whining. That’s because getting the data into its system (which ordinary users actually like) requires adherence to Sanofi’s own data standards.  “People not following data standards became a moot point,” Ricciardi notes.

The company owns the commercial Impact clinical trial management system (CTMS), sold by the Perceptive Informatics division of Parexel, and is happy with it. Indeed, the CTMS data is an important data feed into Sanofi’s system. But the pharma needed more visibility into and across trials and types of data.

Ricciardi described the conception and deployment of Sanofi’s Clinical Trial Information (CTI) system. The goal was to have data fresh enough that people would actually use it. The budget was in the range of $2 million, with just a few full-time employees devoted to the work.

“This is a custom application, but it was built using standard tools in the market place,” Ricciardi told the Forum audience in Philadelphia. “Data is refreshed three times a day.”

The prototype was built in April 2000, and the web-based system is now live and at version 2.1. CTI is now used by 3,200 Sanofi intranet users in 62 countries. Median time from last patient visit to database lock improved 72 percent, dropping from five months to five days in Phase III trials. In a comparison of two individual trials, Ricciardi estimated the system had saved $3.9 million ($700 per patient) by shaving the number of data queries and, crucially, allowing faster decisions.

There were no new systems to learn. Data are only deposited in the CTI system from a variety of other applications that are curated as they always have been. As soon as those systems are refreshed, so is the CTI. There is zero training involved. The web interface was designed to be easy from the start.

The efficiencies are all the more startling because Sanofi is really not doing electronic data capture (EDC) yet. The company is just starting to explore that tool. The CTI system relies on an Oracle database fed by the Impact CTMS and by Phase Forward’s Clintrial clinical data management system (CDMS) and Clintrace safety product. (A migration to the Oracle Clinical CDMS is in the works.)

Sanofi-Aventis Reporting Technology Stack

Source: Sanofi-Aventis and Center for Business Intelligence (CBI)

image Perhaps the most intriguing comment by Ricciardi concerned colleagues clamoring for their data to be in Sanofi’s CTI. “A lot of study teams were not using Impact, for whatever reason,” Ricciardi said. “They were using Excel and just didn’t want to be bothered. As soon as this was available, they said, ‘how can I get that?’ We said, ‘Just put your data into Impact like you’re supposed to.’ We found people insisting that their data were in there. The people running the trial wanted to see it in there.”

In technical programming terms, this means people dining at the Sanofi data restaurant are hungry for what is on the menu and not pushing it ‘round their plates like digital squash.

Says Ricciardi: “From the beginning, demand for this has been very high. It’s very easy to use, very easy to navigate. This is not a traditional reporting tool like Business Objects.” As with customized Yahoo! or Google pages, users can save custom views of data based on their access rights and most common chores.

The next question: did Sanofi-Aventis get anything for its money? The answer appears to be yes. In Ricciardi’s demo, he drilled down into a hypothetical trial in which a hypothetical country, Brazil, was hypothetically under-recruiting patients. Click, click, click.

Pretty soon he was exactly where he wanted to be, at the level of an individual site or investigator. “I’m interested in certain countries that have more problems with data quality than others,” he explained. “I can see which patients have how many data discrepancies, and whether they’re still outstanding, and whether there are case report form pages that are past due.”

That element introduced another subtle aspect to the system: peer pressure. Study coordinators can easily see who is behind. That encourages some of them to keep up. It also lets people in headquarters know what is going on in a single view: “If my study teams are all over the world, it’s difficult to see it all,” he says.

Another feature of CTI is automatic notifications to key trial team members whenever specified events occur.  An example: the locking or unlocking of a clinical database. Such notices have provided early detection of databases locked or unlocked in error. “It’s been so useful,” says Ricciardi. “You’d be surprised how many times the database is locked and the study manager didn’t know it.”

So without even jumping into EDC, Sanofi-Aventis has built a powerful, economical reporting system that seems to serve both upper management and people in the trenches. This is no small feat.

One of the keys to happy customers at all levels of the organization was not making people do additional work, and making sure the information was fresh. “It’s important the information is flowing in in a timely fashion,” says Ricciardi. “The better you get at data acquisition, obviously, the better the information that is showing up for the users at the other end.”

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