If clinical trial data is music, both fluid and potentially dissonant, Peg Regan of PharmaPros is a sort of symphony conductor. She’s the firm’s president and CEO—and has seen plenty of instruments that can prove tricky to coordinate. The ability to combine streams of clinical data remains something that is easy to talk about and hard to do.

PharmaPros is doing it. Regan relates that her firm is neither a pure consultancy (it offers software and a hosted application environment, after all) nor a traditional contract research organization (CRO) (though it offers services in that sphere). “We look to manage the clinical information around the clinical trial,” says Regan.

Systems Galore

The phrase she prefers is “clinical services organization,” or CSO. “We can operate as a CRO for managing data and trials. We don’t do it quite the same way. We want to separate ourselves from the historical viewpoint or approach from a company saying they perform clinical data management. It’s not an over the wall outsourcing model.”

The profusion of systems and rising numbers of projects has created a level of complexity that is not always well understood in the busy pace of a typical day in the industry. “These are still the challenges of the new data acquisition age,” says Regan. “We’re hoping we can add value. The hangover is, it’s still work flow. It’s best practices. The sites have been orphaned. Who supports the sites?”

The Data Life Cycle

That philosophy allows her to work for, or with, every type of company, from sponsor of clinical trials to electronic data capture firms. Regan tells us that most of the sponsor community is struggling to engineer the pipes to link multiple reservoirs of data, using a variety of fixtures and pumps from her firm and others.

She’s blunt about how well that is going. “Companies are caught with their pants down,” Regan says. There has been a flowering in different types of tools, but a shortage of ways to connect them. “It’s caused a challenge in all directions. How do we integrate that data back together so our team can understand the life cycle of the data and where we are in the trial?”

Mapping Exercise

Her team (the Cambridge, Mass. company has 20 employees and a few contractors) must learn as much as it can as quickly as possible. Which vendors are contributing data? When are various types of data due? What’s in the protocol? “We are involved in helping them integrate the data from all these different data sources. We will map out the expectedness of data,” Regan explains, “the timing it should be coming in, the absence of it, the completeness of it.” PharmaPros has an integration tool to tie that together.

Its flagship offering, which is fairly new, is software and consulting rolled up together. It’s sort of an uber-dashboard that might roughly be categorized as a clinical trial management system on steroids. It can pull together systems for EDC, electronic patient diaries, interactive voice response, site management, and drug supply; it can talk to systems from CROs, central labs and imaging specialists. There are tools for reports, workflow design, reconciliation and query management and data exports. Whew.

Data ‘Life Cycle’

“We integrate those systems at the data level,” notes Regan. “We don’t go in and try to change those systems. We integrate them at the data and workflow level.”

At the end of the day, the PharmaPros Electronic Data Lifecycle Management (EDLM) tool is both hosted software and a service. “The one can’t survive with out the other,” Regan says. “EDLM pulls everything together and makes everything seem to make sense.”

Delivering the Deliverable

It’s all very well and good to have this system in-house or that vendor software, she says. But chaos is often the result from too many systems brought together too fast. That seems to annoy Regan as much as a leaky faucet would irritate a plumber. “In our opinion, nothing has happened in the trial unless you have received the data from the trial,” says Regan.

By way of example, Regan cites a company that thought it had collected a number of images for a trial. Those images were duly snapped by the sites. But they were never integrated into the larger body of data for the trial. “A study went through its entire life cycle, and they realized they had never received any CT scans,” she says. “They had logged that they had been requested. At the end, nobody was looking at did they get the data? If you don’t have the deliverable, assume it didn’t happen.”

Show Me The Data

Which is why she doesn’t formally call her system a clinical trial management system (CTMS). “We do this across all systems,” she says. “It could be 10 local labs, electronic patient reported outcomes, interactive voice response, EDC, CT scans, things that we are able to manage. We’re managing what’s going on with the data being collected from those systems. It’s a different focus. We don’t feel the event occurred unless we have the data that proved the event occurred.”

Her system, she says, is ideal for tracking what financial payments sites and vendors are owed. Too often, she says, the mere existence of data in a trial is known, but the quality of that data is not assessed. It is refreshing to hear someone focused not just on the sheer existence of data, but on whether the data are complete and useful in decisions. 

Says Regan: “We can track down to the letter what your vendors are doing. That is not our purpose and our goal. It is interesting how easy it is to utilize the data to do this. Somehow that lab is being paid, but it’s not being checked to see did they deliver the results and did they deliver them correctly. Did they follow the contractual agreement? We can tell that from the data status. There is power in the data that isn’t being fully utilized.”

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