Two hundred people. Yes, 200. A good-sized office building full of them. Their job? Toiling like modern incarnations of ink-stained Dickensian clerks. All day, they cut and paste data from one clinical trial management system (CTMS) into another. Why? So that senior managers can see printed reports that contain fresh, timely information. Which, we are told, is what business school textbooks recommend—managing based on data from the real world.

Even so, throwing manpower at the problem wasn't working.

The unidentified sponsor in question looked around for a better way, and brought in PharmaPros, which (as CEO Peg Regan tells it) was able to use its software and consulting magic to offer a bit more elegance, a bit faster access into the trial's real status. Visibility, in a word, into what is happening during a trial, and not just waiting until the biostatisticians have completed their work at the end. Perhaps by triangulating between the data in three different systems, there is already a wisp of a hint, a possible clue, of a safety issue. Wouldn't it be good to see that?

Sure. There's just one little catch.

In technical jargon, the pharmaceutical industry's preference to combine different types of software from multiple companies is known as the "best of breed" approach. And with human lives and billions of dollars on the line, it's hard to argue that sponsor companies shouldn't select the best technologies they can find. Trouble is, it can be gruesomely difficult to connect dozens of different systems to dozens of other systems, time after time, year after year, trial after trial. Best of breed works. But it is also a recipe for migraines.

Annals Of Integration

Regan doesn't have any philosophical issue with best of breed strategies. "Every company should have the freedom and flexibility to choose the technology they want to use," she says. "We're really enabling the use of all the electronic data acquisition systems. We are not limited by the different solutions they are using or may use in the future."

In essence, she says, the profusion of tools to gather clinical data has created an embarrassment of riches. "They really don't have the adequate tools to manage all the data sources that are being used in a single trial," she says of the sponsor community. "The in-stream analysis side of the house is saying, 'Put it back together for me.' There is tremendous manual processing in terms of extracting to [Microsoft] Excel. This industry is so inherently manually driven. There is a better way. You should be looking for a better way."

Using DataFlow Manager, the flagship system from her Boston-based firm, PharmaPros can aggregate data from different systems into coherent views that are always up to date. "We're able to surface up information that is not just operational. It's trends in the data," says Regan. "Perhaps not about this trial, but about the next one they are going to start soon after. They are using in-stream analysis on this data to design new trials."

'I Don't Know'

In general, Regan believes, there is a bit of growing frustration with zillion-dollar clinical information systems that really don't talk to each other in any way that makes trials something that can be managed.

Across the industry, it's no secret that some project status meetings can be farcical. Absurd. That's not because of any deficit of effort or intellect. It's just thanks to the meager scraps of fresh data that are available on complex projects. Says Regan: "They basically will have executive meetings and project managers come together. They basically say, 'I don't know, I can't tell you.' That's a real pain point. I want people to be able to say, 'I do know, and here's why.' Let me open up the dashboard and show you in real time."

Naturally, her firm's fees vary depending on the complexity of the project. They vary between a few hundred thousand to a few million dollars. The firm uses its software and web services to grab data from multiple systems and give managers real-time access to what is happening across multiple systems and various aspects of a trial. Says Regan: "We don't disturb anything. It's a query. There is no interference, no change to the infrastructure. We don't demand they change anything. It's just this little applet."

New Interdependencies

In the coming weeks, the firm will unveil a new integration between its software and that of Cytel, a biostatistical software firm that specializes in adaptive trial modeling and drug supply forecasting. Together, customers of Cytel and Pharma Pros will have novel in-stream views of a trial to optimize drug supply, predict recruitment, plan dynamic monitoring schedules and estimate the probabilities of success for treatments within a study. This is the sort of thing that only the biggest of big pharmas used to be able to do.

Even in the worlds of contract research organizations (CROs) and technology vendors, Regan reports, there is growing appreciation of the difficulty of syncing up multiple systems from a variety of firms. PharmaPros is currently working with at least three providers of electronic data capture, Medidata, OmniComm Systems and Phase Forward. Says Regan: "Many of the technology vendors are now looking for ways to be more open and avoid the challenges to be able to integrate with ten other systems."

The data visibility issue appears to be an emerging one in the CRO industry, she says. The rise of specialized functional outsourcing providers means that CRO #1 may be highly dependent on CRO #2 to do its job and hit its agreed contractual milestones. That can be hard to do without a key piece of data or even a reasonable guess about when that data will be in CRO #2's possession.

CRO Issues

"You have CROs saying, 'I don't know what's going on at the other CRO,'" says Regan. Just as general contractors work with subcontractors to build a home, a few CROs are volunteering to coordinate the interactions of many firms on a trial.

"There are CROs stepping forward to say they will work with other CROs and offer a best of breed solution," Regan says. "They are very challenged to make sure they can do that. The CROs are a little behind the eight ball in terms of understanding or grasping this." Her technology can help every stake holder—sponsor, CRO, vendor—see enough data to truly work together.

But providing more visibility to sponsors can be a bit anxiety-inducing for some large, established CROs. They've traditionally preferred to control access to progress data and milestones. "The traditional ones are like wait a minute, we are not so keen to provide that information openly," says Regan. "In some cases, that is changing. The sponsors are putting their foot down, 'If I am going to outsource the study, I don't want to do it in a black box.'"

Though she can't name any of the firms she's working for, Regan makes it clear some are large. But even on a smaller project, with just 10 patients, she was able to give the sponsor trending reports that helped it to detect a drug safety signal long before it would have otherwise been intelligible. "The head of clinical research happened to be at that meeting and said, 'I cannot believe we have access to this information,'" Regan says. Naturally, he asked his colleagues if other projects could have similar tools.

Here's an earlier ClinPage article on Regan and PharmaPros.