The clinical trial management system (CTMS) is a software Cinderella in the world of research. By dint of its modesty and centrality to the smooth operation of a trial, the CTMS should be a full-fledged member of the family of tools to support industry-sponsored studies. It isn’t. Yet.

In a chat with ClinPhone’s Michael Smyth, VP of product management for that company’s CTMS, it became clear that one new factor in the niche is demand from the contract research industry. It needs better CTMS tools. Smyth is a former clinical development professional who spent nine years working on trials; he’s worked for big pharma and contract research organizations (CRO).

Reassessing Home-Grown Solutions

Smyth says CROs are energetically talking to ClinPhone about their needs. In some cases, they are viewing investments in CTMS as crucial to long term survival. “We have more CROs contacting us than in the past,” Smyth says. “In the past, they developed their own home-grown system or used [Microsoft] Excel or Word. There are still a lot of them that do that. But the sponsors are demanding real time or near real time access to data from the trial.”

And while EDC companies have gotten much of the limelight, that could be changing, Smyth says. “There is more buzz about creating more systems,” he says. “There are a number of companies that are spending money to develop CTMS.”

Faster Money

ClinPhone’s product used to be called TrialWorks, but has been rebranded ClinPhone CTMS. More than 175 reports are standard; data can be exported into PDFs or Microsoft Excel. All of those reports, he points out, are included; there is no need to buy a separate module or software package to get them.

Investigator payments can be generated monthly or quarterly. Itemized statements help investigators understand just what they did to earn the $5,275 in the most recent check. For one client with many trials, Smyth reports, the payment-generating chore has been reduced to three days; it formerly took three weeks.

Beyond that, a new monitoring module provides offline capabilities to clinical research associates and data monitors; there is also an enhanced data import tool to load data from third-party systems for electronic data capture, interactive voice response and clinical data management.

Easing Integration

“You can integrate it with IVR or any data management system into our CTMS,” says Smyth. “No one manually hand enters that information.”

As trials increase in size and complexity, he notes, some CROs and sponsors come to understand that even managing the contact information for 100 sites is dicey using, say, Microsoft Excel. How do you know your investigator list in a spreadsheet is the most current? What happens if someone accidentally erases it?

Who Owns The Data?

Expanding biotech companies are especially interested in CTMS at the moment, he says. Scaling their trials becomes easier with commercial software. “In the past, they could just use a spreadsheet,” Smyth notes. “When they have a study in Phase II, they realize it would be a lot easier if they had a CTMS.”

And in some cases, sponsors of all kinds that are using CROs understand that it would be optimal to retain the ownership of key data like investigator names and contact details. So if the CRO in question is not used on the next study, or a different CRO is selected, the sponsor doesn’t have to start from scratch. Says Smyth: “They want the data in their own CTMS rather than the CRO’s. If it’s in our CTMS, I have the data in the next study. It’s critical for the biotech company. It’s their data. They want visibility into the study they paid for.”

Microsoft As Starting Point

Smyth says that clinical people are so familiar with the Microsoft Office suite that ClinPhone thought it could be a starting point for its CTMS. “We built it on a Microsoft platform,” says Smyth. “We tried to not make too much of a jump in technology. If you do, people are not going to use it.” The company has a delicate line to walk with Microsoft, because adoption of its CTMS solution depends on a natural insight that can never be rushed: “They realize Excel spreadsheets haven’t worked for them,” he notes.

In the site assessment area of ClinPhone’s CTMS, Smyth takes pains to say, the procedure is objective and quantitative and allows a sponsor to build a list of prospective sites according to any number of criteria. Says Smyth: “It’s not subjective feedback. They can be starting a new study and build an ad hoc report based on indication and investigators who participated before.”

The system can expedite feasibility studies as well, with special reports just for CROs. Once a paper or fax questionnaire is distributed to prospective sites, and the answers are logged into the system, it can generate a report that can be used in the defense of a bid for a project. “It aggregates the information a bit more easily than the way they do it now,” says Smyth.

Systemic Synergies

European demand for CTMS is especially interesting, he says. “We see Europe growing in ways we did not two years ago. Europe tends to be a bit more conservative on technology. They see that people have success with it.”

ClinPhone says that some customers are shopping for more than one system at once. The company’s recent foray into electronic data capture, with the purchase of DataLabs, gives a product suite that is among the broadest in the clinical trial technology sector. Says Smyth: “We’re getting more interest in people already using our EDC solution saying we’d love to hear more about CTMS. There is interest in both.”