It’s the great challenge underneath every clinical trial: finding patients. Can technology help? Can the needle be moved? What role can electronic data capture (EDC) play in finding both patients—and managing the data around patient enrollment? New companies like DecisionView offer one approach with high-end statistics.

But one of the oldest, more experienced firms in the business is BBK Worldwide, where Joan Bachenheimer is one of the founders. We recently chatted with her about a complete redesign of one of the company’s core assets—a suite of tools for sponsors and sites.

TCN eSystems, as it’s called, has been given a new web-interface and brought into the modern era. In all, the tool and its components have been under development for a decade if you count the early versions. At first, of course, they were used by BBK internally. “It was our little secret,” says Bachenheimer. “It was what made us more efficient.”

Although the primary need is to serve the trial sponsor or contract research organization (CRO), Bachenheimer felt the new version of the software would have to support clinical sites. Bachenheimer says her website and the systems supporting it, explain why most of the clinical sites reach their enrollment targets in an industry where that is rare: “TCN had a great deal to do with that. We were able to do midcourse corrections. We had the data. We had a tool to disseminate new tactics.”

The new system has the ability to do data mining on the sites that are performing the best, and that can allow the sponsor of a trial to focus on sites that should get additional resources, or be asked to not participate on another trial. The industry is starting to look beyond individual trials, and individual superhero investigators. Larger patterns, she says, require attention to more data buried across multiple trials. “The big shift in the large pharmas is that they are understanding that they can’t have these pockets. There has to be a centralized group that is looking at efficiencies across all trials.”

The BBK software can help identify which geographical locations or specific investigator sites are likely to have enough patients who meet the inclusion and exclusion criteria. The tool also provides insight into which sites are or are not technologically suited for the trial. “You will not only get a site that is medically able to do the trial but optimized to collect the data,” says Bachenheimer.

Beyond that, Bachenheimer says that recruitment is becoming the fiefdom of more senior managers. Perhaps not C-level executives at the larger companies in the industry, but battle-hardened bigshots all the same. Recruitment is also becoming more of a science and a profession with university degrees in the field on the horizon. “When we started doing this, there was no one internally at these companies who had patient recruitment expertise,” she says. “There was no such thing. Everybody got the sites. And the sites were to bring the patients to the trial.”

That worked, sort of, back in the days when a customer had a single trial to fill. “If you have 50-80 different therapies and a thousand more that are being developed, it’s not as easy to do that,” she says.

With the maturation of patient recruitment, she notes, comes competition. The new software is intended to productize the company’s consultant expertise and stay ahead of the curve. “We see our expertise as practice enhancement and patient recruitment experts,” says Bachenheimer. “We want to be seen as the innovators.”

The goal, she says, is to be a bit like the customer service at Home Depot, where a customer may perform the actual work, but still appreciate guidance about tactics and strategy along the way.

One of the modules in the TCN suite permits customers to begin to use some of the tools routinely used in the rest of the economy. Like supply chain management tools. It’s not just a question of having a great plan, and waiting for that plan to implode or succeed. The software has multiple scenarios that allow the users to experiment and say “what if” with the myriad variables of a trial. “You can go in there and just play to your heart’s content,” Bachenheimer says. “It’s a planning tool that allows you to create scenarios.”

It’s a matter of watching the plan and taking midcourse steps to ensure it succeeds. Says Bachenheimer: “We don’t want people to emphasize just the plan. Midcourse corrections are critical to the success at the end. We want the planning to be an ongoing process that allows for sufficient and effective redeployment as needed.”

It’s hardly news to Bachenheimer that customers have electronic data capture or interactive voice response data that is feeding recruitment dashboards. When TCN was reengineered, she insisted on a modern architecture and signed up netGuru Systems, which put a developer on BBK’s premises in Newton, Mass. “We now have a whole company backing us in terms of the programing and the engineering and the computer science,” she says. During our call, she had Sreenivasan Subbanchattiar, a netGuru VP, on the line, and (while a newcomer to the pharmaceutical industry) it sounds like he appreciates the antiquated nature of some applications in the trade.

That, in turn, makes the integration of data from EDC much easier.  With a template of the data fields from the EDC systems, she says, it’s easy to import XML data into TCN. She’s already working with ClinPhone and it sounds like other partnerships may be in the works.

The key concept, Bachenheimer says, is that you don’t need the whole data iceberg. Just the tip. It’s a mistake to try to ingest the entire data set from the trial. Perhaps ten fields from the database are enough. “To get the most effective reports, you don’t need that much data. You just need to articulate what you need at the beginning,” she says. “You can take your IVR data or clinical trial management system data and you can download that into TCN. Now you can compare actual against your plan.”

BBK is, in some respects, a marketing firm. So it’s no surprise that the company is using the internet to help match patients and trials. But one problem is that many trials do not have a sufficiently long ramp-up time to use traditional search-engine advertising. She’s got a better idea, she says. Bachenheimer sounds especially excited about a forthcoming partnership (going live in the spring of 2007) to flip a switch on a website that will draw prospective patients quickly. “You can’t do search engine optimization,” she says. “You are not up and running long enough for it to get optimized. This tool surpasses direct email opt-in lists and web search advertising.”

There is no question that the technology could be as attractive to CROs as it is to sponsors of trials, but Bachenheimer acknowledges that many CROs do not view their expertise in patient recruitment as lacking in any way. “I think CROs should want this. Whether they will is another case entirely.”

The fee to use BBK TCN eSystems is $15,000 per trial.

Here, from BBK, are some of the specific modules and what they do:

Module 1. Study Forecaster: for planning, reporting, monitoring, and redeployment activities, displayed in easy-to-evaluate charts and graphs.

Module 2. Site Optimizer: for selecting the most appropriate sites and ensuring they are adequately trained.

Module 3. Patient Generator: for conducting efficient and effective patient recruitment outreach and tracking.
Module 4. Materials Manager & Approval Tracker: for developing, gaining, and tracking regulatory approvals of study materials.
Module 5. Retention & Compliance: for maintaining study participation and compliance with the protocols.

Module 6. Study Message Center: for facilitating study community training and communication.