Tailoring IRB software to different sized institutions

Third Sky has options for small, large IRBs

The software demands of smaller IRBs and larger ones can be very different, and it’s hard to meet everybody’s needs with a single program. So Third Sky Inc. doesn’t try.

Third Sky, an information technology company with offices in Boston, Dallas and San Francisco, produces two software products for IRBs — IRB WebKit, which is aimed at medium and large-sized IRB operations, and IRB+ for smaller IRBs. The company also has taken the first steps toward rolling out a third IRB product, aimed more at mid-sized users.

Reginald Lo, vice president-east of Third Sky, says IRB WebKit was the company’s first IRB software product and evolved out of software that had been developed for use at Partners Healthcare in Boston.

IRB WebKit is a web-based, customizable system that allows IRBs to keep track of protocols, as well as IRB functions such as meeting agendas, minutes and continuing review notices. It allows researchers to submit protocols either online or in paper form, and lets IRBs track both processes easily, Lo says.

"For example, frequently the investigational brochure is a big folder and it only comes from the sponsor in a hard-copy form," he says. "So we give the IRB administrator the ability to track whether that has come in. You can submit your protocol online, but you can also put it on hold in your inbox, waiting for the paper documents to arrive."

Ease of use, affordability

Lo says the software is easy for a non-technical user to master. That, and IRB WebKit’s affordability, position it well against other IRB software marketed to larger IRBs, he says. "We’re one of the cheapest within the market for the medium- and large-institution range."

The software allows IRBs to customize letters, minutes and database information to suit their own institutional needs.

Security measures are flexible and can be set to work with existing institutional usernames and passwords. There are different levels of access to the system depending on whether the user is a researcher, an IRB administrator or an IRB member.

When the WebKit is installed onsite, the company also provides training, which usually lasts two to six hours, depending on the level of user. Lo says Third Sky uses a train-the-trainer model for researchers, enabling IRB administrators to conduct researcher training as more researchers are brought into the new system.

He says his company advocates a relatively slow roll-out of the system to researchers, going department to department or by individual users’ technical savvy instead of trying to bring everyone on board at once.

"There’s quite a while where you’re receiving online protocols as well as traditional paper [Microsoft] Word protocols," Lo says. "The IRB office doesn’t want to get overwhelmed by suddenly having every researcher in the organization call up and ask How do I use the new system?’ Hence, we recommend this sort of phased approach."

The licensing fee for the IRB WebKit is based on the number of IRB panels at an institution, rather than the number of users. "We use the number of IRB panels as a proxy for IRB size," Lo says. "It’s easier than trying to remember how many users you have, especially when you’re doing online submissions, where you could have thousands of researchers and that number changes every day."

The fee is $8,000 for the first IRB panel, and $5,000 for each subsequent panel. In addition to the software fee, there is also a fee for professional services such as data conversion, setting up forms, training and onsite installation. Those fees usually run $30,000 to $50,000, Lo says.

The IRB at Baystate Medical Center, in Springfield, MA, switched over to IRB WebKit nearly a year ago from what IRB administrator Maureen Noftall described as an "antiquated [Microsoft] Access database that was on shaky ground."

She and administrative director Richard Engelman, MD, say they’ve been pleased with the software, citing Third Sky’s attentiveness to their needs — and the price of the product.

"We had a number of demos of different products," Engelman says. "Reg [Lo] gave the most reasonable presentation with the product that was the most reasonably priced. And not just by a few dollars — it was a quantum jump cheaper than anyone else."

Noftall says the process of customizing the software for Baystate took only a short time, and she’s been impressed by the company’s response time for questions and other issues.

"Working with Reg and his team of folks has been absolutely wonderful," she says. "If we’re in the middle of an issue, and we give him a call or send an e-mail, they respond within that day, and I find that very refreshing."

Noftall says even the researchers using the software have had surprisingly few requests for changes to the online protocol submission process. "I thought for sure once we rolled it out they’d say, Oh, this is very cumbersome, I don’t like it.’ But we took our forms that we had been using, and just transitioned them into the WebKit. The only difference for them is instead of typing onto an actual paper form, they’re now inputting the information into the WebKit."

Option for small IRBs

For smaller IRB operations, Third Sky offers IRB+, which is an upgraded version of the IRB Navigator software previously marketed by West Beach Software.

Lo says that when West Beach made the decision to stop supporting IRB Navigator, the company asked Third Sky if it wanted to take over its remaining customers.

"We agreed to do it, but we also wanted to improve the technology, so we rewrote it for the Web, while retaining the same look and feel," he says. Lo says about 75% of the remaining IRB Navigator customers have been converted to the IRB+ product.

IRB+ allows an IRB to customize letters and reports to meet institutional needs, but is not as customizable as IRB WebKit, Lo says. "Much more of the structure is already set in stone for you," he says. "So there are no consulting services associated with setting up."

While it lacks some of the flexibility of the IRB WebKit, Lo says it offers an affordable option for small IRBs that want to have online capabilities. The annual fee for using IRB+ is $3,000 for the first user and $1,000 for each additional user. There are additional fees for services such as data conversion, Lo says. Training is conducted online, adding to the cost savings.

Diane Lesmeister, IRB coordinator at Olmsted Medical Center in Rochester, MN, says her institution purchased IRB+ last year to replace an Access database.

"We found a lot of studies that were missed, that we hadn’t corresponded with for progress reports," Lesmeister says. "When they started out they had good intentions, but as the study lists grew, it got harder and harder to keep track and to run queries."

She says IRB+ is a good fit for her IRB, which currently keeps track of 325 active studies.

"We’re not huge, but this is perfect for a small IRB like ours," Lesmeister says. She says one important feature is the ability to export data from IRB+ into a Microsoft Excel spreadsheet, which she can then share with another institution’s IRB.

Lesmeister also praises Lo and his staff for their ability to work with her and turn around solutions to problems quickly.

The one added capability she’d like to see with IRB+ is the ability for principal investigators to be able to submit protocols online.

"What I’m doing right now is copying and pasting information, like a summary of the study into (IRB+)," she says.

Lesmeister soon will get her wish. Lo says Third Sky currently is beta-testing an online protocol submission module for the IRB+ software.

Third Sky plans to add yet another product to its IRB lineup, targeting mid-sized IRBs. Lo says the company recently made a deal with the University of Illinois at Chicago to license that institution’s Research Information Support and Communication (RiSC) software. He says Third Sky will upgrade the RiSC software much as it did with IRB Navigator, and incorporate online submissions as a new feature.

In each case, he says, the goal is to provide customers with greater functionality while preserving the software format they’re accustomed to.

"We make sure each customer community has their own upgrade path," Lo says. "West Beach software customers did not have to learn a totally new system, i.e., IRB WebKit. What we gave them was something very similar to their old IRB Navigator product, except it was on the Web."