Even in 2009, in a context of clinical trials, "management" can mean just about anything. It may mean ... Karen, three cubicles away. Or a 5-year-old spreadsheet. Or a system that cost millions but sits unused. As a result, it's fair to say that clinical trial management systems (CTMS) do not enjoy a reputation for easy implementation, negligible cost or wide usage.
Clinical Force is trying to change that. The small British firm has a U.S. presence in Raleigh, North Carolina. The company is directly confronting what it considers misconceptions about CTMS.
For starters, is a CTMS something requiring a massive capital expenditure? Nah. Do users need to be bullied to regularly put data into a CTMS? No. Is a CTMS something that takes years to design, install and customize? Again, no.
Better CTMS options exist, and as they are understood, the industry will embrace them as eagerly as it has systems for electronic data capture (EDC). "It doesn't have to be this way," says Marcus Thornton, Clinical Force's CEO.
Part of the problem with the clinical trial management software sector, he believes, is that Microsoft Access or Apple's Filemaker applications made it so easy to set up a crude database. He bears no grudge against Access or Filemaker. He does have a problem with people expecting more of them than is advisable in a regulated industry.
People with a tendency to tinker may take a look at Access, spend a weekend fiddling with it—and presto! They believe they have a homegrown CTMS. It wouldn't necessarily allow multiple users. Or be validated. Or be maintained properly over time.
But as one thing leads to another, as one Access database replicates into a dozen, there is a potential for data to be corrupted or lost. "There are a lot of people using Microsoft Access. As a platform, it's not bad," Thornton says. "But the monsters they've created are terrible, truly terrible. People have built pretty dreadful applications. People think they have a CTMS. But they don't. It is kind of scary."
Particularly frightening, he says, is the industry's practice of using Microsoft Excel spreadsheets to store investigator names and contact information. There's no way to know if a report based on a spreadsheet uses all of the data in a huge spreadsheet. If one cell or dependency is changed, the whole spreadsheet may break. "There is no excuse, now, for spreadsheets," Thornton says.
Part of the reason anyone went down that road, of course, is that the dominant participants in the CTMS sector (which include Perceptive, Oracle-Siebel and Winchester Business Systems) are expensive. Getting going with any of the three is a bit like relocating to a foreign country. It's doable. It's possible. But the process is expensive and may not happen quickly.
Thornton's company has taken another approach. Its vision for CTMS is more aligned with firms like Transenda and Study Manager. For starters, like any serious CTMS, he can provide visibility into more than one trial—a limitation of even the best EDC systems.
Beyond that, the cost issue is now off the table. Clinical Force charges a nominal $70 to $150/month per study per user. The company is pursuing a software-as-a-service (SAAS) strategy, in which it takes care of the servers and IT infrastructure and supplies a URL for customers to log into. "The SAAS model makes it perfectly affordable," he says. "You pay per month." He can have you up and running in weeks, not a year or 18 months. Not long ago, we ran a similar story on SAS doing the same thing.
Thornton can credit the major CTMS firms with being more robust than a ginned-up database or quirky spreadsheet. But he thinks the industry can do better. "All most companies have been doing is replacing the spreadsheets. The market is going to change. CTMS have got to start looking at more intelligence-based software at some point."
The CTMS industry, indeed, seems to be enjoying a renaissance of innovation, with new visibility as both sponsors and contract research organizations appreciate access to operational data that are a) not needed for regulatory purposes, b) not gathered by EDC systems and c) of high value in effective clinical trial oversight.
On the functionality front, Thornton says the views of the data in the Clinical Force system are superior to competitors, and credits that with winning deals. Some organizations are trying to abolish spreadsheets, trying to move their data into robust CTMS. Clinical Force's reports have a sufficiently distinctive visual look that makes anti-spreadsheet campaigns easy. "People can sniff out a spreadsheet-based report," Thornton says.
He reports especially strong feedback around the features designed for clinical research associates (CRAs). Rather than using Microsoft Word and spending hours cutting and pasting the same information to or from some other system, the CRA can just write their report. The system matches it to the correct site and autopopulates much of the data. In some cases, trip reports may take one-quarter as much time. That can add up to relatively clear, simple return on investment calculations for Clinical Force, as the company website explains in detail.
Since some CRAs have one day in the office to complete their paperwork for every three or four days on the road, the Clinical Force application has been getting rave reviews. Says Thornton: "The CRAs are saying, 'I'm doing stuff I'm supposed to do. Not copying and pasting it four times.' "
The system promises equally transformational efficiencies with its payments to investigators. As most readers are aware, clinical sites remain in the financial dark ages. They are often unaware whether they have been paid for a particular project, milestone or why. Sponsors, similarly, live in dread that sites will be paid inappropriately. Or not at all. For sponsors, the periodic task of paying sites is something Thornton compares to the process of painting the Golden Gate Bridge in San Francisco. Once you're done, you have to start all over again. It is a source of tedium.
The business logic is entered into the Clinical Force system once, at the outset of the trial. At that point, the system automatically drives payments, freeing humans to do things that humans are good at. "The system doesn't release the payment until you have the visits in house, and you have the case report forms being monitored," says Thornton. "You will never pay for the same visit twice." The system also prints something radical—a letter explaining what the payment is for. "When I show people the remittance letter, they really like it," says Thornton.
At the moment, Thornton reports, perhaps 10-20 percent of customers connect their payment systems into his CTMS. But he predicts the industry is on the cusp of more change, and hopes that the number will increase significantly in a few years.
One reason for integrating financial systems and CTMS is that investigators can log into the Clinical Force system and see what they are owed and what they have already been paid for. There is less laboring in a black hole. The economics of even a routine trial, Thornton suggests, strongly favor spending 15 minutes to process a payment using a good CTMS, vs. perhaps an hour to do it manually.
An Obligatory System?
Thornton claims that he has a larger number of contract research organization (CRO) customers than competitors. Part of the reason, he says, is that the CRO industry is starting to understand the limitations of flying blind. And there's a growing tendency of sponsors to demand the usage of a CTMS, especially for trials of any significant size. "Sponsors are saying to them, 'if you're going to run our study, you must have a CTMS,' " he says.
There may be delicate, case-by-case etiquette issues around immediate visibility into data that are collected by a CRO but financed by a sponsor. In the end, of course, the sponsor calls the shots. Clinical Force can facilitate access to data that sponsors believe they should have without begging, nagging or paying extra.
In some quarters, Thornton believes, there is a sea shift in the making. Its historical precedent may be comparable to what happened with email. At one time, though younger readers may scarcely believe it, email was a novelty. Something possessed only by nerds. Then email became an obligatory element of any business card. Thornton sees a similar shift occurring with the CTMS and, indeed, with web-based CTMS that people actually use to do their jobs.
"We're at the point with CTMS where it is no longer acceptable not to have a commercial CTMS," he says. "In-house developed systems will always struggle to keep up with commercial systems."d9A2t49mkex