Definitions matter. Terms matter. Sloppy language impedes any serious conversation. So we were grateful to be taken to task by Cephalon's Jack Lawler, associate director of clinical solutions.

Lawler is a mild, plain-speaking guy. At least that's our impression from a few conversations. He's a bit irritated, however, at the overall sloppiness of this correspondent's writing and thought. Join the club.

In Lawler's view, it's a stretch--a big stretch--to equate reports out of an electronic data capture (EDC) solution with a full-featured clinical trial management system (CTMS). "The biggest misconception is that you can take an EDC system, throw in a couple of reports--and that's a CTMS. That's a misnomer."

As Lawler points out, the odd, lingering paper trials that may still be under way in any organization present a data analysis challenge. How to merge one trial's paper-based results and three trials' electronic data? "You have no aggregation of that information," he says. "None of [the EDC vendors] give you any mechanism to look at four studies rolled up together."

What is this guy, some sort of EDC-basher? Not at all. "I don't want to present this as if I'm not an advocate of EDC," Lawler says. "I am. It's a great tool. But it's a partial solution. There is no way to make it a true CTMS." It's not enough to get the data from the case report forms into a computer, he says. "That's only a portion of the process."

In his own work, he likes predictive peeks at various benchmarks and milestones. Cephalon uses three different EDC solutions (he declined to name them) and the Impact CTMS from Perceptive Informatics. Impact readily combines paper and electronic studies. A few other tools (for interactive voice response and managing documents) have been integrated into the Cephalon system along the way. Lawler is a happy customer. "We should just allow the data to flow," he says.

Most of the company's new Phase II and III studies are starting in the Impact system, he says. It's worth noting they've got a lot of old CTMS data in there too, going back to 2001. Most of the company's trials are using EDC, it appears.

So what's his definition of CTMS? It should track timelines and plan the trial from soup to nuts. It should have deep metrics. Says Lawler: "My personal opinion is that it's not a CTMS until it covers the clinical trial process," including startup routines and a full dashboard of gauges and reports into how the study or studies are progressing.

Can the CTMS predict when a tenth of the patients will be recruited? "How soon did we get 75 percent of our sites up and running?" Lawler asks. "What sites have performed well? When do we think we'll finish?" Lawler scoffs at the idea that even the best EDC systems will have the data to answer those questions in the short term.

Perhaps half the time he spends in the Impact system, he estimates, is in the planning module. The system is similar to Microsoft Project, Lawler says. Templates for Cephalon as a whole assure some company-wide standards and policies are followed. At the project level and in the trial-by-trial details, the software allows him and his colleagues to do everything anyone in the industry must do--plot timelines, work with protocols, and the generation of a clinical study report.

Because of the multiplicity of ways that money is handled in the trial process, the financial component of any CTMS is one of the most complex elements. Lawler says Impact handles the company's obligations to investigators and allows users to define a particular trigger (a completed case report form moved in-house, perhaps) that sets a payment request in motion.

He's not terribly pleased about the ease with which interactive voice response (IVR) data can be injected into a CTMS. "We've done the gamut, the big and the small," he says of IVR vendors. "The small companies are more easy to work with."

Does that IVR data wind up in the CTMS? "It does happen, but not as easily as people would like it to. Everyone tells you they can do it. When you sit down to do it, it's not as easy as you think." It sounds like his company walked away from one bit of electronic plumbing that was supposed to connect an IVRS to a CTMS.

In Cephalon's case, Lawler believes the CTMS technology has worked beautifully and just maybe helped the company get a bit more done than they would have without it. Who could ask more of any tool? "More people are aware of what's going on, and that's allowed us to execute more programs," he says of Impact. "It's harder to create a CTMS than some people think."

We're not trying to pry. But do you have ANY idea what you're looking for? Can you see ANYTHING down in your data? Or are there patterns lurking beyond your grasp?

Spotfire's DecisionSite is popular in many industries: energy, semiconductors, financial services, and soft drinks, to name a couple. But the heart of the company's user base remains in the life sciences, says Christian Marcazzo, Spotfire's senior director, life sciences marketing. The company is based in Somerville, Mass. but its programmers are in Sweden.

"We become the first place that people try to analyze new data," Marcazzo says. "They don't know what they're looking for. We make it easy to bring that information in and explore those patterns and those trends."

It's a misconception to think Spotfire users only work in drug discovery. Clinical teams are also using Spotfire, Marcazzo says, in big pharmas, biotechs and one or two contract research organizations. "Our customers are concerned about attrition rates in clinical trials, particularly Phase II and Phase III trials. They would like to be better at predicting which trials are going to fail. It's that late-stage attrition that is driving a more rigorous analysis of what's happening in Phase I."

There is not so much a rivalry between Microsoft's Excel spreadsheet and DecisionSite, he says, as an appreciation that almost every customer has Excel and takes a stab at using the spreadsheet for something it wasn't designed for. Says Marcazzo: "They put it in Excel, they see something, and then they cut and paste it into Spotfire to analyze it."

In a demo, Marcazzo put Spotfire through its paces with dummy clinical data. As he works, there is a wonderful quality of serious play--of purposeful fooling around with data to learn what it means.

"I am bringing data from a Phase I trial," he begins. At first, just a standard bar chart is on the screen. But then he clicks on a tabular column of lab values, revealing whether the patients were on drug or placebo. "That's a sanity check," he says. "Are we seeing anything unusual?"

Spotfire customers typically customize the application in many ways, but out of the box Spotfire can flag medically "interesting" patients or batches of records. His demo gets especially impressive when Marcazzo wants to work with subsets of patients. It's not quite as amazing as the scene in the movie "Minority Report" when Tom Cruise puts on the magic gloves and moves data around in thin air. But it's close.

"I want to see the patient who failed six or more tests," says Marcazzo, typing a few keystrokes and selecting the patients with a cursor. Each time he selects a new subset of patients, the changes ripple through several graphs, plots and windows displaying all or part of the data.

"Maybe I want the histogram," Marcazzo muses, "but I take out the baseline and end of study data. Based on that, I can see how the distributions change." As he clicks further, he finds more outliers. Up pops one patient's chest X-ray. This does not mean DecisionSite needs to store thousands of images. "We don't need to have the data in our dataset," says Marcazzo. "We just need an identifier and a URL to go off and fetch that on demand."

Data from SAS, ArisG, Phase Forward or Oracle Clinical can be loaded into DecisionSite as well, but that may require a customization project. Spotfire has a services arm, and can help customers use the application to support specialized needs and integration projects. Says Marcazzo: "We see where their data is. We see who their [human] analysts are and what they need to do. And we map the two together." The process might take 2 months.

In some cases, Spotfire can unite two distinct streams of data -- perhaps adverse events data and clinical data management system data. If the systems to report on each type of data are already well developed and understood by the customer, Marcazzo says, "it becomes a relatively simple exercise to bring the two together."

In more standard cases, "Guide" macros allow a customer's in-house subject matter experts to record each task in a complex series of data-analysis or visualization steps. When a less-sophisticated colleague wants to try the same technique, it's as simple as hitting a button.

For some customers, Marcazzo says, visualization is a collaborative as well as a visual experience. One life science customer has a 12-foot-wide screen.

The screen allows a cross-disciplinary team to convene in a conference room and literally stand up and walk over to a particular cluster on a scatter plot and ask the person "driving" the program to investigate further.

"They'll say, 'Here are some patients that have weird things happening.' And a physician can say, 'yes but....' The whole point is about creating an interactive experience where there is a lot of domain expertise in a variety of end users."