Phase Forward has unveiled a new version of software that helps identify drug safety issues and manage the data in a non-proprietary, Clinical Data Interchange Standards Consortium (CDISC-compliant) manner.

The latest version of the Clinical Trials Signal Detection system (CTSD) includes “a newly developed issue cluster mining technique, enhanced statistical tools such as multivariate Bayesian logistic regression, and expanded signal tracking and data visualization options. The system is also integrated with the company’s Web Submission Data Manager (WebSDM) to offer seamless support for the CDISC Study Data Tabulation Model (SDTM) data standard. The CDISC standard is used to support the CTSD product’s advanced data mining functions.” Phase Forward said.

“CTSD offers our customers an additional level of insight,” said Bob Weiler, president and CEO of Phase Forward. “By enabling our customers to flag potential risks earlier in the clinical trial phase, long before widespread patient exposure to a drug, the product supports improved drug safety and helps manage development costs.”

The news release included a rare statement from CDISC president Becky Kush, who has previously remained zealously neutral on the question of whether any clinical technology vendor is more (or less) compliant with CDISC standards. In this case, Phase Forward’s embrace of CDISC seems to have elicited a reciprocating gesture from Kush.

In the Phase Forward news release, Kush said: “The collateral benefit of applying the CDISC data standard for electronic submissions to additional applications is clear. We expect the CDISC standard to assist with many challenges within the pharmaceutical industry requiring data interoperability—and the application of the CDISC standard to drug safety in clinical trials, as demonstrated by CTSD, is an excellent example.”

As the industry leader, with a cumulative 1,250 trials under its belt and 240 active clients, Phase Forward has aggressively tried to ensure that not even archrival Oracle Clinical can match its ability to work with safety data. The recent acquisition of Lincoln Technologies augmented Clintrace, Phase Forward’s first application in the safety arena.

In a demonstration of CTSD and WebSDM, a longtime CDISC expert and Phase Forward employee took the application through its paces. Sally Cassells is VP of clinical systems at Lincoln Technologies. She reminded a reporter that the SDTM had originally been co-developed with the FDA. The SDTM is basically a program that allows the user to browse through large quantitites of safety data; colors indicate the degree to which a particular data file has been validated or not. “Sponsors can use it as the prepare for a submission to make sure their data is conforming,” says Cassells. “We wanted to come up with basic tools that are non-controversial from a statistical point of view.”

Zeroing in on a particular dataset, Cassells pulls up a screen filled with red and green rectangles. The heat map represents reports of problems according to body part or physiological system. “It’s a guide to know where the rough spots are in terms of your safety profile,” says Cassells. “It sure looks like we’re getting a lot more nausea in the treatment group vs. the comparator group—more than chance alone. These are things you know people are going to be looking at. They’re going to know that as a result of the tables that come with your submission.” The software just makes it easier to identify, explore and understand the issues that are already lurking in the data.

A few more clicks, and she’s probed whether the incidence of a problem was dose-dependent. No, it seems.

At many companies, Cassells says, working with drug safety data, even today, is highly paper dependent. Statisticians may generate a stack of paper. At that point, medical reviewers would leaf through it and attach post-it notes to a few especially interesting pages, which would then be returned to the statisticians for more number-crunching. Weeks or months might pass, and the cycle would be repeated.

Cassells says development of the Lincoln/Phase Forward safety suite is continuing, as is the relationship with the FDA. She says government staffers are testing the company’s tools in circumstances where there is little commercial or scientific data, and finding the software helpful.

“There are plenty of new drugs where there is not a lot of market experience for the class,” says Cassells. “It is a little more wide open. We have a couple cases of FDA reviewers using the heat map to understand the big picture. They find it reassuring that they have the whole world view. We are still working with them in a number of areas. Some of the safety reviewers have started to use the CTSD functionality. We have continuing contact there. We’re also involved with the a team at the FDA developing tools around the Janus data warehouse. There are several tools in the toolbox that go on top of Janus. Ours is one of them.”

Separately, Phase Forward is integrating its products with reports from business intelligence firm Cognos. That Canadian company has a powerful suite of tools for analyzing trends, but ordinary mortals may have difficulty tapping what Cognos can do. “It gives you a point and click interface for the reports,” says Phase Forward’s Judith Hanover. “It’s an actual embedded implementation of Cognos within Clintrace. It will allow our Clintrace users to get a broader look at safety.”