In an industry with so many seasoned people, why do so few trials finish on time and at budget? If we can send people into space, shouldn’t we know what it will cost to study a new antibiotic?

ClearTrial may be able to bring some modern managerial brio to the issue of what clinical trials cost and why. It is a relatively new company out of Chicago.

The company probably has more glowing, effusive testimonials from customers than any we’ve seen in years. In one case, a customer from Searle (prior to its acquisition by Pfizer) estimated his company saved $16 million on plans for just two large trials. “We’re seeing that if you use the software on two studies a year, you will see anywhere from a four to 10-fold return on your investment,” says ClearTrial’s managing partner and chief operating officer, Michael Soenen.

Soenen says that his customers are gravitating toward a cost-analysis technique that is common in service industries but not yet widely used in the life sciences: activity based costing. But his tool is designed for non-accountants. “It was built by clinical people for clinical people,” Soenen says of the company’s platform. “That is probably one of the most important aspects. It speaks to our users in a language they understand, which is clinical.”

Granular Detail

In contrast to traditional accounting for clinical trial budgets, which use averages collected from many studies, ClearTrial allows clinical people to go into its system to tweak at least 120 standard variables according to the trial at hand—not some cumulative attempt to average out the trial at hand.

Still, the company has data, plenty of it, allowing users to fine-tune design considerations in about 70 countries, 160 therapeutic indications and 130 documented trial parameters. ClearTrial supports both old-style outsourcing and functional outsourcing. It allows the user to estimate full time employees needed for a trial based on both in-house resources and outsourced staffing, both single- and multiple-CRO trials.

Not For CPAs

Soenen says that simplicity was a crucial design criterion: “If software is too complex, too sophisticated, it doesn’t get used. It takes too much time to use it. It becomes shelfware. It has to be fast. It has to be easy to use.”

Soenen himself has a background in software, but he’s put in time at Kraft Foods and Andersen Consulting as well. ClearTrial’s conceptual heritage, he tells us, is in the manufacturing sector, where eager sales teams sometimes returned with customer requests for customized products that factory assembly lines simply could not construct. In the manufacturing sector, Soenen reports, software was developed to assess the viability of a request before a customer was disappointed. In the life sciences, such disappointment is typically deferred for a few years until it is too late to go back to the drawing board.

New Budget In Seconds

Budgeting, it turns out, is only a fifth or a sixth of what ClearTrial does. It also helps clients plan and simulate trials so that operational and budgetary surprises are minimized. The idea behind the software is that it can crank out a variety of scenarios far faster than any spreadsheet, with a wealth of granular detail.

As clinical trial professionals ponder those scenarios, they can run the simulation again to squeeze the cost or allow an appropriate amount of time for patients to enroll. Says Soenen: “If I do this, if I do that, what does it look like? In minutes, the software will show you. ClearTrial can show you how to achieve the optimal balance between those constraints to hit whatever your business goal happens to be.”

To take one example, the Clear Trial system can account for differences in individual countries, and compute the impact of slightly faster recruitment in one country or slightly lower costs in another. Will electronic data capture be used? Whatever the design parameter, says Soenen, “We can modify our algorithm to keep pace with that industry. Traditional tools cannot do that.”

Assessing Your CRO

In some cases, sponsors of clinical trials are using ClearTrial as a hedge in planning trials actually managed by contract research organizations (CROs). Before putting out a request for bids from CROs, such sponsors are looking at their project, and privately calculating what the cost should be. Soenen reports that the tool helps both sides know what a reasonable bid for a trial should be.

The software helps the CRO win resources that are truly necessary for the trial, and to encourage more intelligent brainstorming than abrupt demands to cut 10 percent off the bid. Says Soenen: “Instead of that, you take a more collaborative approach. What if? What if we move patients to Latin America?” In seconds, based on whatever assumptions are changed, a new estimate will be available.

Microsoft Integration

Soenen takes pains to say the company doesn’t pick sides. It just tries to refine its algorithms, like Google tuning its search engines, to produce more accurate results over time. “We are not a CRO,” he says. “We are not a sponsor. We are able to be a neutral third party for keeping those algorithms.”

The system is web-based, and can instantly produce a new estimate if only a single variable is changed.

At the end of the process, it integrates seamlessly into Microsoft Project and Office. That’s a somewhat tricky selling point, because part of the company’s pitch is that Excel is simply inadequate for planning large trials. Without knowing which version of a trial planning spreadsheet is current, or even what the intent of its creator was, it can be hard to decipher what some obscure alphanumeric abbreviation or assumption is. In ClearTrial’s system, by contrast, experts can save trial templates to be used by lesser mortals, and all the assumptions are plain as day.

Will Excel Wither?

Soenen reports that the spreadsheet has lost its luster as a planning or budgeting tool. “These things tend to have grown over time and they become so brittle that someone tries to make a change and they don’t know what they are breaking in the background.”

We had categorized the company, in our usual rough way, as a clinical trial management system (CTMS). Soenen set us straight. “We’re not out to replace a CTMS by any stretch. We can integrate with them. It can be done on multiple levels.” In some cases, information from ClearTrial may be exported into Excel, and then uploaded into a CTMS.

Fair Warning

One of the most intriguing features of the ClearTrial software is that it flags projections or predictions that are ... ahem ... too aggressive. If senior managers or Wall Street or some unnamed individual way above the process has an unrealistic expectation about a study timeline, the data and knowledge base in ClearTrial will flash an alert.

Soenen is diplomatic about this. He recognizes its not ClearTrial’s place to tell anyone how to run a trial, but simply to provide the most accurate estimates it can. “It’s going to pop up a warning and say, ‘We don’t think you’re going to have any sites approved by that date.’ However, the software will not prevent you from doing something you know you can do. ClearTrial cannot possibly know everything you know. It will advise you and warn you. Then ClearTrial will show the impact of that assumption.”